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

Services

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."

News

03-02-2016 Top expert on electrical safety in medical devices, Jack Voorbrood, joins Qserve Group

To further strengthen its fast growing team of experts and increasing presence in Europe, US and China, Qserve is happy to welcome Jack Voorbrood to its team.

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11-12-2015 International Devices & Diagnostics Monitor

FDA News published short interview with Gert Bos about the future of device regulations.

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07-12-2015 Clinica: How the unexpected can pack a punch in Medtech regulations

Clinica, the leading source on the medical devices and diagnostics industries, had an exclusive interview with Gert Bos about Medtech regulations and his career change to industry consultant.

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