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. 

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