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:
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: