December 10, 2018
ISO 14155 - Good Clinical Practice in the spotlights!
By reading the MDR the trend seems to be that there is increasing attention for clinical, by referring to sufficient clinical evidence of sufficient quality. Personally, I cannot be happier! Clinical is my favorite topic of interest, but let’s be honest, clinical decision making can be complex and activities are costly. Therefore,..

Your Global Medtech Partner for Regulatory, Clinical & Quality Compliance

Qserve is the largest consultant company in the EU that is 100% focused on medical devices and In-Vitro Diagnostics. Check out our company video.

Europe

Our knowledge of the European Medical Device Regulation (EU-MDR) ensures that we can train and support you with an efficient regulatory strategy.

China

We can help you navigate through the Chinese market by offering a wide range of customized services.

USA

We have supported hundreds of Medical device manufacturers with FDA submission. Qserve’s legal entity can act as US Agent and Official Correspondent.

Why choose Qserve as your regulatory consultant?

 

  • We know exactly what should be prepared to become and stay in compliance with the regulations
  • Strong international team with technical, regulatory quality and clinical competence.
  • Ex EU Notified Body, FDA, and CFDA staff.
  • Full Medical Device CRO services
  • We have a team where we use multiple levels, from junior to principal. Depending on your project we are able to form a cost-effective team.
  • We charge you for the work performed, no hidden costs.
  • We train and we leave something behind, a regulatory compliance imprint.
  • 1 contact point giving you access to a broad team with all expertise.
  • Legal representation in China, Europe and United States

 

Our method

"Our mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements."
Jan van Lochem , CEO

News

December 10, 2018

ISO 14155 - Good Clinical Practice in the spotlights!

By reading the MDR the trend seems to be that there is increasing attention for clinical, by referring to sufficient clinical evidence of sufficient quality. Personally, I cannot be happier! Clinical is my favorite topic of interest, but let’s be honest, clinical decision making can be complex and activities are costly. Therefore,..
December 10, 2018

What will be the impact of the EU MDR on clinical data collection in Investigator Initiated Studies?

An Investigator Initiated Trial or Study IIT/ IIS is a research effort in which the investigator designs and implements the clinical study and the investigator acts as the study sponsor. As the sponsor, the Investigator assumes all responsibilities for complying with applicable regulatory requirements. 
December 10, 2018

Key Opinion leader engagement for your clinical investigation

Key opinion leaders (KOLs) are experts and thought leaders in their field. They are an important resource for R&D, market access and clinical investigations. KOLs can add great value to your clinical investigation by helping you develop a credible study protocol with scientifically relevant outcomes.
December 10, 2018

Where do Clinical Evaluation and Clinical Investigation meet?

A clinical investigation is often the keystone of evidence to prove that your medical device is ready to enter the market. 
December 07, 2018

DIS 14155 standard available

Some news regarding the upcoming update of the ISO 14155 standard, the draft international standard (DIS) version is now published.
December 03, 2018

New guidelines for overseas clinical trial data in China

The National Medical Products Administration (NMPA) (formerly the China Food and Drug Administration or CFDA) has released new guidelines on preparing clinical trial data generated overseas.