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.
Regulations vary depending on the medical device and market you wish to enter. Our specialized teams will help you comply with all necessary regulations.
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.
Ensure that all quality performance requirements are met by implementing and maintaining a Quality Management System (QMS) based on local requirements.
"Our mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements."
The 2016 annual summary report on Medical Device Registration in China is out!