July 21st - FREE Regulatory Webinar: MEDDEV 2.7.1 Rev 4
What are the changes in the MEDDEV 2.7.1 Rev 4 - Clinical Evaluation in the EU for Medical Devices? And more important, what will be the impact? 
 
 

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

RSS

July 11, 2016 Qserve fills full program at RAPS San Francisco Chapter with revised MEDDEV 2.7.1.


Keith Morel presents at RAPS San Francisco Chapter: Chinical Evaluation in the EU for Medical Devices - Changing Expectations
Raps has invited Keith Morel, VP of Regulatory Complaince at Qserve Group, to share his expertise on the approved MEDDEV 2.7.1.

Read more

July 07, 2016 Gert Bos interviewed by Clinica: For How Much Longer Is Your CE Marking Valid?

In another interview with Clinica, Gert Bos (executive director of Qserve) clarifies in the case of the MDR how to interpret the MDR transition arrangements.

Read more

July 07, 2016 Qserve Group exclusive training at BSI Shanghai

Today the founder of Qserve, Willibrord Driessen, presents at the BSI MedTech Club in Shanghai, about the EU MDR and how to implement.

Read more