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Regulatory Affairs

Full Service- Planning, Testing, Approval and Certification

The requirements for the approval of implants and medical devices in the national and international markets have increased worldwide in recent years.  The regulatory requirements are complex and vary from region to region. In addition to the reqiurements of the MDR and the FDA it is above all the Notified Bodies  that represent a major hurdle in the approval process for implants


This makes approvals in the target markets particularly difficult for manufacturers and presents them with special challenges and issues. These are in particular:

  • Is there already an approval for the specific product?
  • Which procedure must be observed?
  • Which requirements must be met?


Consulting, planning and testing from a single source has therefore proven to be an ideal combination, providing the best possible information about the medical device and significantly accelerating the development and approval process.

 

Planning and Testing / Clinical Evaluation

Mechanical testing - planning and evaluation  - The mechanical safety of a medical device must be demonstrated via preclinical mechanical testing.


Clinical Evaluation - The aim of a Clinical Evaluation according to MEDDEV 2.7/1 rev.4 is to demonstrate the in vivo performance and safety of a medical device. This evaluation is based on a systematic literature search and an analysis of all relevant data.

 

Approval and Certification

Our partner Medcer offers extensive know-how and in-depth experience of the approval in the target markets for medical device. His portfolio includes in particular:

EU 2017/745 MDR

FDA- Registration

Clinical Studies