June 7th, 2018
Qserve, the leading European medical device and IVD consultancy group, has opened a German office. This development significantly enhances Qserve’s ability to service the medical device and IVD market in Germany, the third largest medical device market worldwide, as well as servicing its global customers.
The German office will be located in Karlsruhe and will be represented by Dr. Stefan Menzl who is a member of Qserve’s global team since October 2017.
Before joining Qserve, Stefan was Global VP Quality & Regulatory Affairs at several medical device manufacturers including Edwards Life Sciences, Abbott, AMO and Paul Hartmann. Stefan and his team combine strong experience in quality, regulatory compliance and clinical affairs with a pragmatic, result driven approach at both operational and strategic level.
Qserve Germany will focus on supporting medical device and IVD manufacturers to gain compliance to the new MDR and IVDR requirements. Worldwide Qserve is the leading consultancy partner for MDR/IVDR implementation projects and provides MDR and IVDR training worldwide. For manufacturers in Germany, Switzerland, and Austria, Qserve will organize MDR and IVDR training as well, for details see our events calendar.
Besides MDR/IVDR support, Qserve offers support for market access to the US and China. Projects will be managed from the German office, using our local experts in the Qserve offices in those countries. This global footprint, together with more than 800 years of combined team expertise makes Qserve your local partner for worldwide compliance.
As a full-service CRO, Qserve also manages clinical trials in Europe. By integrating its expertise in regulatory compliance and its close connection to major Notified Bodies, Qserve is able to design and execute the optimal clinical strategy that delivers the clinical data needed to achieve clearance for devices while using existing data where possible.
Jan van Lochem (CEO): “I am very happy that we can now serve German-speaking manufacturers. Our team has such a wealth of regulatory, quality, clinical and management experience through many years in industry as well as at Notified Bodies. The German office will further strengthen our services to support our customers in the increasingly challenging regulatory environment while building Qserve’s European presence as the leading EU regulatory, quality and clinical partner for the MedTech industry”.
Dr. Gert Bos (CTO, and former head of Notified Body BSI Germany): “Our German team, that participated in working groups of European and German industry organizations, are excellent trainers and consultants. Their wealth of experience dealing with the EU-MDR discussions that took place over recent years will give them the advantage to go the extra mile for our customers.”
About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible.
Qserve’s global team combines their regulatory and clinical knowledge and experience in the medical device industry, sharing more than 800 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, and quality services.