Gert Willem Bos, FRAPS

CTO, Executive Director & Partner at Qserve Group
Qserve Group Inc. - ENTERPRISE

Gert is an expert in European regulations based on sufficient years hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS.

Presentation(s):

• Demystifying the EU MDR: From Transition to Implementation

  Saturday, September 21
  9:00 AM – 5:00 PM

• Broad Stakeholder Panel Debate on Status of Implementation of the EU Medical Device Regulations MDR and IVDR

  Monday, September 23
  10:30 AM – 12:00 PM

• Solution Circle: EU-IVDR: How Lessons Learned From EU-MDR Can Help Focus EU-IVDR Implementation

  Tuesday, September 24
  12:15 PM – 12:45 PM