ISO13485 QMS Conversion training
What is the difference between the existing ISO 13485 and the just released 2016 version? Custom made training to learn about the differences and 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

May 19, 2016 Qserve hosts medical device regulatory seminar in Newport Beach

On May 4th, 2016 Qserve hosted a successful seminar in Newport Beach, California on the current challenges and changes in the medical device regulatory landscape in the European Union.

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May 17, 2016 Scrip Regulatory Affairs: Stricter Equivalency Requirements

Major changes in the current guideline on clinical evaluation of medical devices (MEDDEV 2.7/1, Rev 3) have been approved, among them stricter requirements for demonstrating equivalency between a device under evaluation and an approved product.

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May 11, 2016 Gert Bos interviewed by Clinica: Time Right For MDR/IVDR Completion

The European Commission’s original September 2012 proposals for a new EU Medical Device Regulation and IVD Regulation have progressed far enough and it is now time to adopt new rules. Read more why the time is now right and what the implications are for those elements that were added by the European Parliament and Council.

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