The regulation of Medical Devices and Health Products enforces thoroughness in the application of the regulations and the generation of supporting documentation.
The demanding regulatory framework for Medical Devices, currently in the process of change, requires a high level of control over all phases of the product life cycle in order to guarantee patient and user safety (design and development, Product commercialization, production, storage and distribution, installation, service and removal).
We can help you in the following areas:
Regulatory advice
Implementation of new regulation MDR (EU) 2017/745
Implementation of new regulation IVDR (EU) 2017/746
Medical Device Classification
CE marking
International product registration including FDA 510 (k)
MDSAP
Preliminary license to operate facilities
Consulting and implementation of Quality Systems according to ISO 13485 and 21 CFR 820.
Risk Analysis and Management according to ISO 14971.
