18th of October -Webinar: Clinical Evaluation
Qserve's Expert, Keith Morel will be talking about the most significant changes in MEDDEV 2.7.1., why demonstrating 'equivalence' will become more difficult and how often your CER should be updated during the product lifecycle.  

Practical support to accelerate your market approval

Our philosophy is to optimize and customize our advice using a practical approach to support each individual company in the most efficient and cost-effective manner. 

Regulatory Compliance

Regulations vary depending on the medical device and the market you want to enter. Our specialized teams support you to comply with all necessary regulations.

Clinical Evaluation

Verify the clinical safety and performance of your medical device by analyzing clinical data. Assessment can be based on existing literature or a clinical study.

Quality Assurance

Ensure that all quality performance requirements are met by implementing and maintaining a Quality Management System (QMS) based on local requirements.

All expertise fields


How can we help you?

Qserve offers a full regulatory service package for medical device development. Together with our partners, we assist you in chosing the most favourable strategy and taking all necessary steps getting your medical device on the global market.


Our method

1 partner

"Choose 1 partner for medical device regulatory. With the right partner you realize your company’s full potential. Qserve is such a partner."



October 20, 2016 Qserve’s first Roadshow-Training combination was a great success!

On the 28th of September, 2016 the Qserve roadshow and training took place at the Headquarters of Qserve, in Arnhem, The Netherlands. We were very pleased with the demonstrated interest and positive responses that were submitted through evaluations, completed by 85% of the attendees. Both morning and afternoon presentation sessions consistently received ‘above average’ ratings in the evaluations.  

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October 11, 2016 Where are you on the road to EU-MDR compliance?

Qserve is a global regulatory consulting firm, specializing in EU-MDR compliance. Dr. Gert Bos, EU-MDR specialist and leading Qserve’s efforts around the EU-MDR states: “Training on the significant changes in the EU legal framework is essential in 2017 to prepare manufacturers for effective implementation the coming years”

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September 21, 2016 China Business Development and Sales expert, Minghua Chen, joins Qserve Group

To further strengthen its fast growing team and to increase the growth in China, Qserve is happy to welcome Minghua Chen to its team. Minghua brings 13 years of professional experience in sales, marketing and business development in medical device industry to the Qserve Group.

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