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