February 15, 2018
Will ANVISA’s acceptance of ISO13485 certification be the end of MDSAP?
October 2017 ANVISA, the Brazilian regulatory authority, published resolution RDC no. 183 stating that for medical device manufacturers located outside the Brazilian territory and Mercosur, a different approach regarding granting of Good Manufacturing Practices (GMP) will be taken.

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

February 15, 2018

Will ANVISA’s acceptance of ISO13485 certification be the end of MDSAP?

October 2017 ANVISA, the Brazilian regulatory authority, published resolution RDC no. 183 stating that for medical device manufacturers located outside the Brazilian territory and Mercosur, a different approach regarding granting of Good Manufacturing Practices (GMP) will be taken.
February 12, 2018

18th RAPS Netherlands Chapter meeting

February 06, 2018

The Brexit Challenge: Truth or Dare?

As the month February moves on, we see a storm in the news on the Brexit challenges and opportunities Do we still have time to sit back and relax? Or do we agree with Raphael Hogarth in yesterday’s Times that “it will soon be too late to salvage the Brexit trade talks”?
February 05, 2018

US FDA and EU IVDR diverging in regulatory approach towards genetic testing

With the newly EU IVDR just published and with the US FDA interpretation on current legislation maturing, it is time to reflect on the direction authorities are taking towards genetic testing. On first review, it is clear that there will continue to be significant differences between FDA’s application of US laws and regulations and those of the EU in vitro Diagnostics Regulation (EU 2017/746). 
February 01, 2018

What are the effects of the European MDR on Chinese Medical Devices manufacturers?

The new EU-MDR has been published on May 5, 2017 and will come into effect on May 26, 2020. This new Regulation is more explicit than the current legislation, which means that the Medical Device sector will need to increase its general level. To help you understand the impact of the new EU-MDR on the Chinese medical device manufacturers, we have asked two of our experts: Minghua Chen and Jan-Paul van Loon, to share their first experiences from a regulatory consultant’s perspective.
January 29, 2018

What to expect in 2018 for the MedTech sector

As we have come back from our Christmas break and started our work in the new year again, I want to take the opportunity in this blog to look ahead at what 2018 might bring us and what we need to prepare ourselves for. The MedTech sector awaits another year full of challenges and adjustment, especially considering the dynamic regulatory environment in Europe.