Quality Assurance and Regulatory Affairs
Medical Device Test and Compliance
Available for: Full time, part time, tasks
- Management and project management.
- Design and implementation of QMS.
- Design Controls and DHF.
- Testing Strategies and Implementation.
- Implementation of the V-model.
- Design verification –Test protocols/test reports.
- Medical Device Files.
- Risk Management.
- Post Market Surveillance(PMS) and Vigilance.
- Experienced auditor.
- Management Representative.
- Qualified Person.
- Medical Marketing and product launches.
- Implementation of QMS and ISO 134845:2016 certification at RD-Support.
- Implementation of QMS at Optoceutics and Measurelet.
- Antia Therapeutics AG ISO 13485:2016 upgrade Easyx Liquid Embolic integrated in Qmedics.
- Market introduction and sales of Easyx Liquid Embolic.
- Clinical Studies (Class IIB and Class III).
- CE-Mark Class IIB.
- ISO 13485:2012 certification.
- Prior to that multiple medical device product launches.
Extensive knowledge in:
- MDR 2017/745, IVDR2017/746, ISO13485:2016 [Medical Device & In Vitro Diagnostic Directive, and QSR].
- EN ISO 14971:2019 [Risk Management].
- EN ISO 19011:2018 [Internal Audit].
- MEDDEV 2.12-1 rev 8 [Vigilance].
- MEDDEV 2.7/1 revision 4 [Clinical Evaluation].
He believes in practical solutions that works for people. He has hands on experience in all aspects of startups and large medical device companies including extended Regulatory and Quality experience. He can do the job himself as well as teach and coach.
He is an excellent cook and spend his free time mountain biking close to the summerhouse where he is also working on projects. He is married for a lifetime and has two daughters.