August 30, 2017
Do you have sufficient clinical evidence for future EU-MDR compliance?

This blog looks at the impact of the new regulation on clinical studies you already performed, and clinical data you collected under the MDD, and challenges everyone’s decision to not perform additional clinical trials or PMCF studies.

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

August 30, 2017

Do you have sufficient clinical evidence for future EU-MDR compliance?

This blog looks at the impact of the new regulation on clinical studies you already performed, and clinical data you collected under the MDD, and challenges everyone’s decision to not perform additional clinical trials or PMCF studies.

August 24, 2017

Interview with Inette Nieveen on the Medical Device Regulatory changes in Europe

To help you understand the impact of the EU MDR, we have asked one of our experts to share her first experiences from a Regulatory consultant’s perspective, and therefore, we have set up an interview with Inette Nieveen. She has been involved in complex MDR implementation projects and is able to identify critical bottlenecks in the process. 

 

August 21, 2017

Consultation process under the new MDR - Is there anything new under the sun?

An increasing number of medical devices requires a consultation process under the new EU-MDR. Only then, an EU technical documentation assessment certificate can be issued for the device. 
August 16, 2017

An EU-MDR question from a customer, Keith Morel shares his extended answer.

As an EU-MDR expert, we are always willing to answer questions and share knowledge about the EU-MDR. This time, Keith Morel, VP Regulatory Affairs, gives an answer to a question about the use of Harmonized Standards in Clinical Evaluations, which might be interesting for all medical device manufacturers.

July 25, 2017

Funneling the bottlenecks! – The quest for clarity

So, what is everybody up to these days? Scheduling a family summer break or frantically working on the MDR project? Most important before you leave your laptop and find some quiet reading spot on a beach with a nice view, is to ensure you have funneled the bottlenecks you have so far identified into the clarification machines in Europe.
July 11, 2017

Five reasons to start your MDSAP readiness now!

For a long time GHTF and its successor IMDRF have focused on providing guidance and harmonization. But recently they have moved to the next level of harmonization in practice. The first project is the so-called MDSAP program, the Medical Device Single Audit Program.