October 10, 2018
5 practical ways to streamline your IT system validation
Validation of IT systems is a requirement by both the FDA 21 CFR QSR regulations and the ISO 13485 standard. The 2016 version of this ISO standard has been aligned with QSR and extends the validation scope with IT systems used in the Quality Management System, such as training, CAPA, and complaint handling systems. 

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

October 29, 2018

Qserve Spotlight on Loes Pelgrim, Clinical Team Member

Interview with Qserve's consultant Loes Pelgrim
October 10, 2018

5 practical ways to streamline your IT system validation

Validation of IT systems is a requirement by both the FDA 21 CFR QSR regulations and the ISO 13485 standard. The 2016 version of this ISO standard has been aligned with QSR and extends the validation scope with IT systems used in the Quality Management System, such as training, CAPA, and complaint handling systems. 
October 10, 2018

A new outlook for the Medical Device industry: Shanghai releases 100 initiatives for economy expansion

Shanghai’s 100 opening-up measures unveiled on the 10th of July sent a jolt of excitement to both foreign and domestic industry leaders. Shanghai, well-known the financial center of China, is aiming to improve its service and manufacturing industries.
October 02, 2018

Interview with Stefan Menzl: MedTech Training Program 2018-2019 (part 2)

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.  
October 01, 2018

Qserve Spotlight on Wiebe Postma, Clinical Team Member

Interview with Qserve's consultant Wiebe Postma
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.