May 4th, Orange County USA
Qserve Orange County Seminar: Key upcoming European regulatory changes and how if affects YOU

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."


26-04-2016 Thanks to all for making the Qserve conference a success!

On 4 and April 5, 2016 the Qserve Conference at the Burggolf Hotel (Greater Amsterdam) was organized. We are thankful that 80% of the attendees completed the evaluation. The analysis shows an overall rate of 4.5 (on the scale of 5). The organizing committee is proud to host more than 125 attendees over the two days.

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19-04-2016 US Seminar Orange County: European Regulatory Changes

How to upgrade for ISO 13485:2016 and prepare for the upcoming EU MDR quality system requirements in one go? This approach will be taken on the next Qserve US Roadshow, May 4th in Newport Beach, CA, USA. We will focus on the details of the new ISO 13485, as well as on the upcoming changes in the European Legislative overhaul.

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17-04-2016 Meet our Qserve team at the CMEF in Shanghai, April 17-20,2016

A Networking Reception will be held on April 18 from 3:30pm to 5:00pm in the Holland Pavilion. The Consulate General of the Netherlands in Shanghai will also be present. If you are interested in participating, please contact Stephanie Huang.

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