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."


30-11-2015 Leading representative of European Notified Bodies, Gert Bos PhD, joins Qserve Group

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.

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27-11-2015 Qserve Conference 2016: Save the date!

Through the great success of the last two editions, we are delighted to announce that in 2016 there will be a third edition of the Qserve Conference. This event will take place on 4-5 April at the Burggolf Hotel in Purmerend (greater Amsterdam). 

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27-11-2015 RAPS Netherlands: Sponsored by Qserve

Subject of the 11th meeting will be ‘Cybersecurity, Data Protection and Forgeries’, touching an important issue as everyday more medical devices exchange data using the internet.

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