Our Academy

We have extensive experience in courses and training delivery.

We can train individuals, groups or whole companies in relevant regulatory requirements, on both general and detailed matters.

We can deliver training at your premises, providing a cost-effective way of training larger groups of people.

We have established course curriculums with proven past results, yet we are just as able to adapt our courses to your specific needs.

When it comes to our academy: we are committed to excellence!

Our courses

Medical Device Sterilisation

The course gives a basic introduction to industrial sterilization of medical devices. The course will focus on the different industrial sterilization methods used for medical

This course is an introduction course for equipment validation. The course introduces the basic disci- plines within Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification

Medical Device Documentation

This course explains all key documents required for each phase of a develop- ment project. This course can also be arranged as 1⁄2-day course.

Good Documentation & Test Practice

This course is going through all the documentation rules and explains why these rules are important to fulfil in relation to the safety of the

GMP for Medical Devices

This course gives the participants a solid knowledge of the different GMP requirements related to the develop- ment and manufacturing of a medical device. This

Human Factor Engineering – IEC 62366

This course makes participants capable of planning and performing a small HFE study according to IEC 62366 standard requirements.

Risk Assessment – ISO 14971:2019

This course makes the participants capable of performing FMECA risk analysis according to ISO 14971:2019 standard for devices and production equipment. This course includes a

MDR, CE Marking & FDA Approval

This course is focusing on European approval process and the content of the Medical Device Regulation (MDR), but is also introducing the FDA approval process.

Design Control – 21CFR820.30

This course goes through the different development phases and the different key documents for each development phase; from Design Planning to Design Transfer.

Our Academy

Our courses

Medical Device Sterilisation

Equipment Validation

Medical Device Documentation

Good Documentation & Test Practice

GMP for Medical Devices

Human Factor Engineering – IEC 62366

Risk Assessment – ISO 14971:2019

MDR, CE Marking & FDA Approval

Design Control – 21CFR820.30

Managing Partner in Medical Device & QA

Søren Lyngsø-Petersen

Shall we chat about the particularities of your project?

Pharma4ever

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Do you want to know more about Finished Products Engineering?

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Do you want to know more about Finished Products Engineering?

Do you want to know more Process Engineers?

Do you want to know more Medical Device & QA?

Do you want to know more about Finished Products Engineering?

Do you want to know more Process Engineers?

Do you want to know more Medical Device & QA?

Do you want to know more Medical Device & QA?