Profile

Gert Bos, FRAPS, PhD

Contact Details

Netherlands
Board of Directors
RAPS Fellow
Chapter Officer
Bronze Member
RegEx Pro

Bio

Gert is an expert in EU-MDR and further European regulations based on 15 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 nonactive device area. For his contributions to the regulatory profession over the last decade he has been awarded as Fellow of RAPS

Education

Twente University
PhD
1993 To 1998

Universiteit Twente
MSc
1987 To 1993

Current Organization Type

  • Consulting Firm

Job History

Interim Technical Manager Medical Devices
January 2015 - present

Head of Notified Body
March 2013 - present

President
October 2011 - present

Certification Manager
May 2010 - present

Head of Regulatory and Clinical Affairs
September 2009 - present

NB representative
January 2009 - present

Vice-chairman (chairman 2006-2011)
October 2006 - present

CEO
January 2017 - present

Member of the Board of Directors
January 2017 - present

Member Program Committee Euromeeting 2017
February 2016 - present

Executive Director & Partner
January 2016 - present

Board member and co-founder of Dutch Chapter
January 2012 - present

Principal certification manager & technology manager medical devices
February 2003 - August 2009

Principal certification manager
January 2003 - August 2009

Business Developer
January 2000 - January 2003

postdoc researcher
January 1998 - January 2002

postdoc researcher
January 1998 - January 2002

PhD student
January 1993 - January 1998

Highest Degree Earned

  • Postgrad

Regional Interests

  • Asia

Product Interests

  • Combination Products
  • IVDs
  • Medical Devices