Compliance With EU MDR General Safety and Performance Requirements (GSPRs) by Application of Standards

Dr. Bassil Akra is CEO and one of the owners of the QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

Sabina Hoekstra is founder and principal of EUMD Consultancy, specializing in regulatory advice to the health products industry. Sabina has 20 years of experience as pharmaceutical and medical device regulator in the Dutch government, serving subsequently in the Medicines Evaluation Board, Ministry of Health and CCMO (governmental organization for clinical investigations). She has represented the Netherlands and EU in several in several international working groups. She has worked as Lead for European Regulation in Philips, where she acted as leader and expert in European Medical Device and Pharmaceutical Regulations and Standards on corporate level. She was involved in Philips’ EU MDR/IVDR Implementation Program. She was Vice-Chair of the EU Regulatory Affairs Focus Group and Chair of the Clinical Working Group in COCIR and Member of Regulatory Affairs Committee in MedTech Europe.

Sabina has a long track record as volunteer in global professional organizations (DIA and RAPS) and she is a regular speaker and faculty member in educational conferences on regulatory topics.

Sabina was co-founder and chair of RAPS Netherlands Chapter and chair of the RAPS European Council (REC). She is Fellow of RAPS and staring 2020 she will serve in the RAPS Board of Directors.

Martin Witte is Global Director for the Focus Teams Active Implantable and Cardiovascular Devices, in his current role Martin is leading an international team of experts and auditor providing conformity assessment services on high risk medical devices. Additionally Martin is leading the local team for active implantable medical devices at TÜV SÜD Product Service in Munich. Martin started working with TÜV SÜD in Feb. 2014 and had prior to that a role as Regulatory Affairs Manager in BIOTRONIK, Berlin focusing on Defibrillatory, Pacemakers, MR Conditional devices and leads. This role he had for 6 years and prior to starting in industry Martin studied Biomedical Engineering in Hamburg.

Dr Peter W Bowness, Technical Team Manager with responsibility for devices utilising materials of animal and human origin, IVF/ART and organ preservation joined the British Standards Institution in 2012 from industry, after leading projects to develop mesh and injectable collagen implants for guided tissue regeneration and soft tissue reinforcement and bulking in clinical areas such as hernia repair, abdominal wall reconstruction, breast reconstruction, fistula, obesity and soft tissue deformity. Previous experience includes management of GMP stability and drug release testing for recombinant antibody therapeutics.

Dr Bowness is technical specialist conducting conformity assessments for devices utilising materials of animal origin, surgical implants and surgical instruments and is Chair of the British Standards technical committee for symbols and labelling in medical devices and a member of the UK technical committee for risk management in medical devices.

• Studies of chemistry & biochemistry (University of Munich, LMU)
• Ph. D. in organic chemistry (University of Munich, LMU)
• Postdoc in organic and analytical chemistry (University of Jeddah, KAUST)
• R&D lead at medical device manufacturer for ophthalmics (alamedics)
• Team lead for chemical analysis of medical devices (UL International)
• Team lead for biological, chemical, biocompatibility testing of medical devices (TUV SUD Product Service)

Andreas Purde studied electrical engineering in Munich. After some time in the automotive semiconductor industry he went back to university working in the field of optical surface measurement. He started at TÜV SÜD 14 years ago as auditor and test engineer for functional safety - he now leads the German departments for active medical devices.