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June 17, 2019

Press release: Sue Spencer leading expert IVD joins Qserve

Qserve Group, the leading global medical device and in vitro diagnostics consultancy, training and CRO company, is welcoming Sue Spencer, further expanding its capabilities to support the IVD industry worldwide. Sue is the leading expert on EU IVD certification, having 35 years of IVD experience in industry and Notified Bodies.

June 14, 2019

China launches electronic registration system for medical device approval

China NMPAformer CFDArecently announced that the implementation of Electronic Regulated Product Submission system (e-RPS) will come into effect on June 24, 2019.  The format and arrangement of content stipulated are now part of the regulatory requirements to file for NMPA submission.

June 13, 2019

EU-MDR and EU-IVDR Booklets for sale in two convenients sizes

We are proudly introducing you our newest items. The Qserve MDR and IVDR in two convenient sizes. One for on your desk and one for in your bag. 
June 12, 2019

What Manufacturers Need to Know About China’s Overseas Inspections

China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors. Gert Bos, PhD, FRAPS, executive director and partner with Qserve Group, addressed the topic during a session at the recent RAPS Regulatory Conference Europe in Brussels. Bos and his Qserve China colleague, Michael Yan, answered some questions about China’s inspections program in the following Q&A.

June 06, 2019

Interview with Gert Bos, Executive Director & Partner.

‘The situation regarding the delay in the designation of notified bodies under the new EU medical devices regulations is looking so critical that some member state competent authorities have even started discussing whether they should step in and assess the conformity of some of the products themselves’ 

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