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 market you wish to enter. Our specialized teams will help you comply with all necessary regulations.

Clinical Evaluation

Analyze clinical data to verify the safety and performance of your medical device. Assessment is based on existing literature and clinical studies.

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 choosing the most beneficial strategy to get your medical device to 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

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January 19, 2017 Mindy McCann, an experienced Regulatory Compliance expert joins Qserve as a Principal Consultant

To futher strengthen our growing team of experts and increase presence in the US, Qserve is happy to welcome Mindy McCann to its team. Mindy brings many years of industry and Notified Body experience in Regulatory Compliance, Quality and Clinical.

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December 20, 2016 MEDDEV 2.7.1 Rev. 4 webinar in the top 5 of popular Medical Devices Webinars


The webinar "Understanding the Changes in MEDDEV 2.7.1. REV 4"  by Keith Morel, VP of Regulatory Compliance at Qserve Group is in the top 5 of most popular free Medical Device Webinars of 2016 at greenlight guru.

 
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December 13, 2016 More speakers confirmed for our 2017 MDR workshops!

We are happy to have Philippe Soly, Director of Regulatory Affairs at Philips Healthcare on the 16th of January, Benjamin Hagendorn, Head of R&D Regulatory Affairs at Merz on the 26th of June and Sophie Tabutin, Notified Body Regulatory Lead at Bsi on the 16th of October as a speaker at our upcoming EU MDR Compliance workshop program 2017. 

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