September 17, 2018
GMDN Eh!
The GMDN was compiled based on international standards in the early 1990’s.  The work was mandated by the European Commission to support the implementation of the first European Medical Device Safety Directives. 

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

September 17, 2018

GMDN Eh!

The GMDN was compiled based on international standards in the early 1990’s.  The work was mandated by the European Commission to support the implementation of the first European Medical Device Safety Directives. 
September 03, 2018

Are you fully trained for the new regulations?

The implementation of the MDR presents many new challenges to medical device manufacturers. As a response to the new Medical Device Regulation introduced by the EU in 2017, Qserve designed a series of trainings which focus on the fundamentals of the new MDR. These valuable training courses only touched on the fundamentals of the EU-MDR. 
September 03, 2018

Qserve Spotlight on US Team

Qserve Group is pleased to announce that we have expanded our US team of consultants in response to the growing demand for worldwide Regulatory, Quality and Clinical support, including MDR/IVDR related projects. 
September 03, 2018

Interview with Stefan Menzl: MedTech Training Program 2018-2019

Qserve offers medical device manufacturers training at all regulatory, quality, and clinical levels. As a global medical device consultancy with offices in Europe, the United States and China, Qserve's staff offers years of international experience, with both broad and specific expertise for a wide range of medical devices and IVD's. In this interview, we highlighted several questions for Stefan Menzl, Executive Director of Qserve Group Deutschland GmbH.  
 
August 31, 2018

Key legislative revisions in EU for Combination Products: Is your Re-registration of your Device or Drug on Track?

The combination product market is growing and will continue to do so with advances in medical technology paving the way towards safer and more efficient patient care. Drug-device combinations like prefilled syringes, refillable implantable reservoirs, regenerative patches, and automatic dose delivering units help reduce user errors and improve treatment options. Products that combine medicinal products for human use and medical device are bridging the divide between the pharmaceutical and medical device industries. 
August 30, 2018

An Overview of Common Gaps in Clinical Evaluation Reports (CERs) and Technical Documentation Under the MDR

Among the many daily activities performed by a medical device manufacturer, uniform compliance to the MDR for technical documentation is an especially time-consuming challenge. At Qserve Group, we are here to help analyze and identify a wide array of potential gaps across Clinical Evaluation reports, as well as technical documentation (such as Design Dossiers and Technical Files). An awareness of potential compliance gaps is an important first step towards planning a pathway to MDR compliance.