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.
Søren is IRCA certified lead auditor of the ISO 13485 standard and have a long experience with sourcing and supplier management activities.
Søren has a background as Toolmaker and Mechanical Engineer which gives him a practical and pragmatic “angle” on the different quality and authority challenges in the medical device world. Søren has more than 12 years “hands-on” experience with filing of medical devices in both EU and US.
Quality Management Systems expert incl. IRCA certified lead auditor within ISO 13485. Teaching within ISO 13485:2016 and development, implementation and maintenance of Quality Management Systems in different medical device companies. Long experience working with ISO 9001, ISO 14001 and OHSAS 18001. Top Management representative for more than 12 years, CAPA and NC handling and trending. Managing of more than 50 authority and pharmaceutical customer audits during the last 13 years. Post Market Surveillance management incl. Complaint management and market vigilance and finally more than 10 years’ experience within Supplier Disaster Management.
Regulatory Affairs for new products for identification of the most optimal regulatory pathway. Preparation of the Regulatory Compliance Plan for new development projects, Class I, II and III devices. Preparation of regulatory related documentation such as Essential Requirement check list/General Safety and Performance Requirements, 510(k) documentation package, Device Master File documentation package for combination products and other direct related regulatory documents. Cooperation and communication with FDA in connection with both pre-submission and submission processes. Long experience of coordination with Notified Bodies.
Quality Assurance covering preparation of requirement specifications for all types of production equipment for the healthcare business according to current GMP. Preparation of Quality Activity Plans. Performing of FMEA and FMECA Risk analysis according to international standards. Preparation of FAT/SAT protocols, test documents and reports. Preparation of CE documentation including operation and maintenance manuals.
Validation within production equipment covering performing of risk management processes, preparation of Master Validation Plans & detailed validation plans. Preparation of validation protocols (IQ, OQ, PQ, MQ). Preparation and performance of qualification activities, worst case analysis and preparation of SOP’s.
Device Development according to FDA 21CFR820 including Design Planning, Development & Quality. Design Input – Device Specifications (URS/PRS). Design – Review throughout the development phases, Engineering testing, Design Output – Design Verification Testing, Design Output – Design Validation Testing (HFE studies). Design Output – Life cycle Risk Assessment Process and Design transfer process.
Employee Management with more than 15 years of experience with employee management as Director for different departments in different companies in Denmark & Poland.
Project Management within the pharmaceutical business. Running a number of different projects from a few hundred thousand DKK and up to more than 500 mill with a project organisation of more than 75 people.