December 21, 2017
Ending an important year in European medical device regulations
Now that we are approaching Christmas and prepare for the holidays, it’s time to look back on 2017

Practical support to accelerate your market approval

Qserve is the largest consultant company in the EU that is 100% focused on medical devices.  We are able to provide you with detailed knowledge and experience on the broad range of expertise needed. We have subject matters experts (SME) on all aspects of medical device regulation. 

Regulatory Affairs

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 Affairs

Experience a practical approach based on your existing regulatory data. Our team supports medical writing of clinical evaluations (MEDDEV 2.7.1.), as well as full-service CRO activities.

Quality Assurance

Ensure that all quality performance requirements are met by implementing and maintaining a Quality Management System (QMS) based on local requirements.

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

January 02, 2018

Looking back on Qserve's MDR advanced training course in 2017

On December 11, Qserve organized the final session of the 2017 MDR advanced training course, that consisted of 10 separate events, one day per month. The final session was a full day open panel discussion with the Notified Bodies.
December 21, 2017

Ending an important year in European medical device regulations

Now that we are approaching Christmas and prepare for the holidays, it’s time to look back on 2017
December 18, 2017

How are manufacturers paying for Notified Body struggles?

The increasingly challenging environment, that EU notified bodies find themselves operating in, is translating into some real headaches for device and diagnostics manufacturers. 
December 15, 2017

The commission has published a new version of the borderline manual

The most remarkable is the classification decision on a cardiac bypass procedure related cannula, that after decades of discussions are now classified as class III products.
December 12, 2017

European NBOG Designation Codes for Notified Bodies are officially published

“These codes have been long-awaited, as they form the basis of the notified body designation under the new EU MDR and EU IVDR,” Gert Bos, executive director.
November 28, 2017

What is the impact of the General Data Protection Regulation (GDPR) and the EU-MDR on medical devices that process personal data?

Since the increasing connectivity (Internet of Things) of medical devices over IT-Networks, like cloud solutions and the rapid integration and use of software applications (standalone or integrated), data protection is an essential requirement to preserve patient safety.