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Contact us
  • Proces Engineering
  • Finished Products Engineering
  • Medical Device & QA
  • Pharma4Ever Academy
  • Team
Menu
  • Proces Engineering
  • Finished Products Engineering
  • Medical Device & QA
  • Pharma4Ever Academy
  • Team
Career
7
Contact us
  • Proces Engineering
  • Finished Products Engineering
  • Medical Device & QA
  • Pharma4Ever Academy
  • Team
Menu
  • Proces Engineering
  • Finished Products Engineering
  • Medical Device & QA
  • Pharma4Ever Academy
  • Team

Medical Device & QA

Are you working within the medical device or IVD area? Then Pharma4ever QA is the right partner if the time schedule is tight, or if you are looking for special competencies.

Are you working within the medical device or IVD area? Pharma4ever QA is the ideal choice if you’re working on a tight schedule, or need specialist competencies. 

  • Pharma4ever QA provides specialist assistance in the following key areas:
  • Authority Legislations e.g. EU, US, JP, CMDCAS
  • Quality Management System, ISO 13485, ISO 9001
  • Regulatory Expertise within MDD/MDR, IVDR, MDSAP, FDA, cGMP
  • Risk Management Processes according to ISO 14971:2019
  • Biological Evaluations
  • Clinical Evaluations
  • Statistical Disciplines
  • Design Control incl. DHF establishment
  • Device & Equipment Qualification and Validation
  • Usability Engineering
  • Internal and External Audit Performance
  • Supplier Management
  • Education & Training Programs

With solid working experience in each of the areas listed above, we are committed to help you achieve the best possible results within these core disciplines, and any corresponding fields.

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The dual combo of vast experience and the agile, flexible setup of our organization makes Pharma4ever QA the perfect partner for medical device, pharmaceutical and biotech companies.

Select the case category of your interest

Authority Legislation
Ad-hoc regulatory support for small companies
Quality Management System
Design History File
Equipment Qualification & Validation
Statistical disciplines
Education & Training Programs
Biological & Clinical Evaluation
Supplier Management
Desktop Audit and Gap Analysis
IVD Equipment
Authority Legislation

Authority Legislation cases

Detail knowledge within the new Medical Device Regulation.
EU MDR
Long hands-on experience with the FDA Regulation.
US FDA
Practical experience with certification according to MDSAP
MDSAP
Detailed experience with interpretation of cGMP requirements
cGMP
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Next
Detail knowledge within the new Medical Device Regulation.
EU MDR
Long hands-on experience with the FDA Regulation.
US FDA
Practical experience with certification according to MDSAP
MDSAP
Detailed experience with interpretation of cGMP requirements
cGMP

Authority Legislation profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Ad-hoc regulatory support for small companies

Ad-hoc regulatory support for small companies cases

Determination of the device class and regulatory pathway.
Regulatory clarification
Hands-on experience with both NB and FDA approval processes of medical devices and combination products.
Authority Approval
Preparation of thousands of documents gives us a solid knowledge of the required content level of documents
Documentation Level
Determination of the right quality level is essential for profitable production
Basic Quality Requirements
Determination of the right quality level is essential for profitable production
Basic Quality Requirements
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Next
Determination of the device class and regulatory pathway.
Regulatory clarification
Hands-on experience with both NB and FDA approval processes of medical devices and combination products.
Authority Approval
Preparation of thousands of documents gives us a solid knowledge of the required content level of documents
Documentation Level
Determination of the right quality level is essential for profitable production
Basic Quality Requirements
Determination of the right quality level is essential for profitable production
Basic Quality Requirements

Ad-hoc regulatory support for small companies profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Quality Management System

Quality Management System cases

Extensive experience in implementing quality systems in small and large companies.
QMS structure
We prepare procedures that fulfills standard requirements and can be understood by everyone in the organization.
Procedures
Our experience says that a combination of user-friendly templates and instructions, reduce number of documents in the system
Instructions & Templates
We have a long experience in performance of training sessions of the organization and in performance of internal audit events.
Training & Internal audit
Previous
Next
Extensive experience in implementing quality systems in small and large companies.
QMS structure
We prepare procedures that fulfills standard requirements and can be understood by everyone in the organization.
Procedures
Our experience says that a combination of user-friendly templates and instructions, reduce number of documents in the system
Instructions & Templates
We have a long experience in performance of training sessions of the organization and in performance of internal audit events.
Training & Internal audit

Quality Management System profiles

Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Design History File

Design History File cases

We know how you plan an effective development progress
Development planning
A clear specification of requirements is the basic for a device development process
Design Input
We know which documents that must be generated for justifying the design of the device.
Design Output
A statistical based testing of both functionalities and usability is the key for an effective authority approval
Design Verification & Validation
We have a solid experience in ensuring an effective transfer from development to production
Design Transfer
Previous
Next
We know how you plan an effective development progress
Development planning
A clear specification of requirements is the basic for a device development process
Design Input
We know which documents that must be generated for justifying the design of the device.
Design Output
A statistical based testing of both functionalities and usability is the key for an effective authority approval
Design Verification & Validation
We have a solid experience in ensuring an effective transfer from development to production
Design Transfer

Design History File profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Equipment Qualification & Validation

Equipment Qualification & Validation cases

Long experience with preparation of equipment requirement Specifications.
Requirement Specifications
Preparation of both Validation Master Plans and individual Validation Plans.
Validation Plans
Performance and facilitation of FMEA/FMECA risk analysis in accordance with ISO 14971:2019 standard.
Risk Assessment
Extended experience in preparation of IQ, OQ & PQ protocols.
Validation Protocols
Solid hands-on experience in performance of validation activities and reporting according to authority expectations.
Validation Performance & Reporting
Previous
Next
Long experience with preparation of equipment requirement Specifications.
Requirement Specifications
Preparation of both Validation Master Plans and individual Validation Plans.
Validation Plans
Performance and facilitation of FMEA/FMECA risk analysis in accordance with ISO 14971:2019 standard.
Risk Assessment
Extended experience in preparation of IQ, OQ & PQ protocols.
Validation Protocols
Solid hands-on experience in performance of validation activities and reporting according to authority expectations.
Validation Performance & Reporting

Equipment Qualification & Validation profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Statistical disciplines

Statistical Disciplines cases

Achieve stable, predictable, and capable manufacturing processes by simple statistical tools.
Statistical Process Control (SPC)
Use statistical tests and analyses for evidence-based decision making during development and troubleshooting.
Statistical Test and Analysis
Calculate statistically based sample sizes for Design Verification and Process Validation
Sample Size Determination
Use statistical sampling to determine acceptability of production lots of raw materials and finished products.
Acceptance Sampling
Optimize manufacturing processes and increase your process understanding
Design of Experiments
Employ predictive methods to predict and substantiate durability and shelf-life claims
Reliability/Durability Estimation
Previous
Next
Achieve stable, predictable, and capable manufacturing processes by simple statistical tools.
Statistical Process Control (SPC)
Use statistical tests and analyses for evidence-based decision making during development and troubleshooting.
Statistical Test and Analysis
Calculate statistically based sample sizes for Design Verification and Process Validation
Sample Size Determination
Use statistical sampling to determine acceptability of production lots of raw materials and finished products.
Acceptance Sampling
Optimize manufacturing processes and increase your process understanding
Design of Experiments
Employ predictive methods to predict and substantiate durability and shelf-life claims
Reliability/Durability Estimation

Statistical Disciplines profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Education & Training Programs

Education & Training Programs cases

We have performed more than 200 courses within a broad range of topics related to the medical device and pharmaceutical business.
Courses
One of our strong tools are that we easily can design a course directly adjusted to the specific needs of the company or individual.
Individual needs
We have a specific education program for training of internal auditors within ISO 13485 / ISO 9001, MDR and cGMP.
Education of internal auditors
Previous
Next
We have performed more than 200 courses within a broad range of topics related to the medical device and pharmaceutical business.
Courses
One of our strong tools are that we easily can design a course directly adjusted to the specific needs of the company or individual.
Individual needs
We have a specific education program for training of internal auditors within ISO 13485 / ISO 9001, MDR and cGMP.
Education of internal auditors

Education & Training Programs profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Biological & Clinical Evaluation

Biological & Clinical Evaluation cases

The biological evaluation of materials and substances is one of the key authorities focus areas. We have consultants with a solid experience within this area.
Biological Evaluation
The Clinical Evaluation and Clinical Investigation have had an increase attention with the new Medical Device Regulation. We know the authority expectations for the content of a clinical evaluation plan and report and we have a solid experience within literature search and preparation of CER’s.
Clinical Evaluation
Previous
Next
The biological evaluation of materials and substances is one of the key authorities focus areas. We have consultants with a solid experience within this area.
Biological Evaluation
The Clinical Evaluation and Clinical Investigation have had an increase attention with the new Medical Device Regulation. We know the authority expectations for the content of a clinical evaluation plan and report and we have a solid experience within literature search and preparation of CER’s.
Clinical Evaluation

Biological & Clinical Evaluation profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Supplier Management

Supplier Management cases

You normally says that 80% of your challenges are caused by your suppliers. We have a long experience in identification of the right suppliers within a broad range of components.
Sourcing – Supplier Identification
The supplier approval process can be done on different levels. We are experts in performing of supplier audits, we have a pragmatic approach where we are focusing on the parameters that are specific for the suppliers delivery performance.
Sourcing – Supplier Approval & Maintenance
Preparation of purchase specifications and supplier contracts is the key to a quality delivery by the supplier. We have a long experience in preparing these documents.
Purchasing
Previous
Next
You normally says that 80% of your challenges are caused by your suppliers. We have a long experience in identification of the right suppliers within a broad range of components.
Sourcing – Supplier Identification
The supplier approval process can be done on different levels. We are experts in performing of supplier audits, we have a pragmatic approach where we are focusing on the parameters that are specific for the suppliers delivery performance.
Sourcing – Supplier Approval & Maintenance
Preparation of purchase specifications and supplier contracts is the key to a quality delivery by the supplier. We have a long experience in preparing these documents.
Purchasing

Supplier Management profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

Desktop Audit and Gap Analysis

Desktop Audit and Gap Analysis cases

Do you want a second opinion before a authority inspection or do you need to now exact where you need to improve? We have a good experience in performing desktop audits within different areas e.g. QMS.
Desk-Top audits
If you need to know the exact gap between your present documentation and a new regulation or standard, we have a long experience in this kind of work. We are experts in the legislations and key standards within the medical area.
Gap Analysis
Previous
Next
Do you want a second opinion before a authority inspection or do you need to now exact where you need to improve? We have a good experience in performing desktop audits within different areas e.g. QMS.
Desk-Top audits
If you need to know the exact gap between your present documentation and a new regulation or standard, we have a long experience in this kind of work. We are experts in the legislations and key standards within the medical area.
Gap Analysis

Desktop Audit and Gap Analysis profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
Se profil og cv

Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
Se profil og cv

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
Se profil og cv

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
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Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
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Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
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Keld Schmidt

Senior consultant
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IVD Equipment

Desktop Audit and Gap Analysis cases

Do you want a second opinion before a authority inspection or do you need to now exact where you need to improve? We have a good experience in performing desktop audits within different areas e.g. QMS.
Desk-Top audits
If you need to know the exact gap between your present documentation and a new regulation or standard, we have a long experience in this kind of work. We are experts in the legislations and key standards within the medical area.
Gap Analysis
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Do you want a second opinion before a authority inspection or do you need to now exact where you need to improve? We have a good experience in performing desktop audits within different areas e.g. QMS.
Desk-Top audits
If you need to know the exact gap between your present documentation and a new regulation or standard, we have a long experience in this kind of work. We are experts in the legislations and key standards within the medical area.
Gap Analysis

Desktop Audit and Gap Analysis profiles

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
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Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
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Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
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Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
Se profil og cv

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
Se profil og cv

Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
Se profil og cv

Keld Schmidt

Senior consultant
See all employees

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Managing Partner in Medical Device & QA

Søren Lyngsø-Petersen

Shall we chat about the particularities of your project?

  • +45 42 70 20 90
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Do you want to know more about Finished Products Engineering?
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  • +45 30 72 21 30
Do you want to know more Process Engineers?
  • JH@Pharma4ever.com
  • +45 31 33 82 14
Do you want to know more Medical Device & QA?
  • SLP@Pharma4ever.com
  • +45 42 12 58 53
Do you want to know more Medical Device & QA?
  • SLP@Pharma4ever.com
  • +45 42 12 58 53
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