Gert W. Bos, PhD, Fraps

Executive Director & Partner

Leading MDR-Expert

Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting.

He is a president-elect and member of the Board of Directors of RAPS, founding member of the Board of Directors of RAPS Europe and a founding board member of the Dutch RAPS Chapter.

Gert provides strategic consulting on complex regulatory matters, on interactions with Notified Bodies and EU pharma agencies, on suspensions and cancellations of certificates, field safety corrective actions and more. He is supporting due diligence processes from RA/QA perspective. And finally, he provides insightful dedicated in-house training on regulatory matters, including EU-MDR and EU-IVDR. 

Before joining Qserve, he served 7 years as Head of Regulatory and Clinical Affairs of BSI (NB0086) and Head of Notified Body at BSI-Germany (NB0535), and a similar time as head of the certification team at KEMA (now Dekra, NB0344).

He has served as President of the Notified Body Association TEAM-NB, and as Chair and Vice-Chair of the Medical Notified Body forum NB-Med in Brussels for over a decade. In these roles, he represented Notified Bodies in many EU Commission meetings and workgroups and represented Notified Bodies in the process of drafting and finalizing the EU-MDR.  

Please do not hesitate to contact me if you have any regulatory issue. Always happy to discuss details!

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