Leading representative of European Notified Bodies, Gert Bos PhD, joins Qserve Group

November 30, 2015

To further strengthen its fast growing team of experts and increasing presence in Europe, US and China, Qserve welcomes Gert Bos as new partner and member of the board of directors. Gert is a leading spokesman on behalf of European Notified Bodies and a key contributor to the development of the European medical device  and IVD regulations. He has given Europe a voice around the globe in IMDRF, AHWP meetings and as a frequent speaker at conferences and expert panels. The regulatory professionals network RAPS showed its appreciation earlier this year awarding Gert with the title ‘Fellow of RAPS’. The addition of Gert’s regulatory knowledge and network will further strengthen Qserve’s position as a global leading regulatory consultancy firm for medical devices. Gert joins Qserve on January 1st, 2016.

Gert has a PhD in biomaterials, hemocompatibility and tissue engineering, post-docs in pharmacy and currently works at BSI as Head of Regulatory and Clinical Affairs (globally) and Head of Notified Body (Germany). Earlier in his career, Gert worked in the pharmaceutical development company Octoplus. In 2003 he joined KEMA (now DEKRA) to become a product expert, reviewer, QMS auditor and project manager in a broad range of non-active medical devices and IVD’s. Given his background in both materials and pharma, he worked a lot in borderline and drug-device combination products.

Gert served six years as chair, and subsequently four years as vice-chair of NB-MED, the official meeting of all Notified Bodies to promote harmonization, interact with stakeholders such as European Commission, Member States and industry representatives, producing NB-MED guidance documents on interpretations of the EU Directives for medical devices. Over the past 5 years, his role grew in importance as the primary representative of Notified Bodies, helping to shape the new Medical Device and IVD Regulations. Gert is also a member of the working group writing the new MEDDEV 2.7.1. on clinical evaluation. 

Four years ago Gert became President of Team-NB, the branch organization of key Notified Bodies, where he lead the organization to further harmonization and gave Notified Bodies a voice in the debates with European Commission, Parliament and Member States regarding legislative changes.  

Jan van Lochem, CEO of Qserve Group, says: “Gert’s addition emphasizes Qserve’s role as top expert in European and global regulations and will help our clients in all key regions worldwide to prepare for the upcoming changes in especially EU regulations. Gert joining will further strengthen our service to US manufacturers, after the recent opening of a new office in Silicon Valley and Keith Morel joining earlier this year.” 

Gert is looking forward to this new challenge, “I already know Qserve for many years and appreciate their expertise and their international and practical approach. It is truly an interesting opportunity to join a globally leading regulatory consultancy firm, especially now the EU MDR and new ISO 13485 coming into force. As a principal expert I can support medical device manufacturers worldwide to stay in compliance.”   

 

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