June 18, 2018
The REALITY of the EU-MDR timelines
Gearing towards summer, the last key conference on EU-MDR was held last week in Brussels: the MedTech week hosted together with Informa and MedTech Insight. A significant portion of the event was focusing on the impact of the new EU-MDR and on exchanging views on how to solve the many unclarities and impossibilities.

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.

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

June 18, 2018

The REALITY of the EU-MDR timelines

Gearing towards summer, the last key conference on EU-MDR was held last week in Brussels: the MedTech week hosted together with Informa and MedTech Insight. A significant portion of the event was focusing on the impact of the new EU-MDR and on exchanging views on how to solve the many unclarities and impossibilities.
June 11, 2018

Qserve Spotlight on Nadira Salah, Quality Team Member

Interview with Qserve's consultant Nadira Salah

June 07, 2018

Qserve expands global presence in MedTech with German office

PRESS RELEASE - June 7th, 2018
 
Qserve, the leading European medical device and IVD consultancy group, has opened a German office.
June 07, 2018

Qserve erweitert seine globale Präsenz im MedTech-Bereich durch die Gründung einer Niederlassung in Deutschland

PRESSEMITTEILUNG
7. Juni 2018

Qserve, die führende europäische Consulting-Gruppe für Medizinprodukte und IVDs, hat eine deutsche Niederlassung eröffnet.

June 06, 2018

The 4th edition is nearly there: EMC testing for medical devices – are you prepared?

In both the US and the EU by the end of 2018 application of the 4th edition of IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests are mandatory.
June 04, 2018

Clinical investigation of medical devices for human subjects - Good clinical practice (GCP)

Good Clinical Practice (GCP) is a well-known and important quality concept in clinical trials.