Case Studies
Request:
Outcome:
Request:
Outcome:
Request:
Risk Management Analysis (ISO 14971:2019)
Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.
15.7.2022
Patient information management (IFU, Labelling and Cartons)
A ‘Label’ is the identity of the product.
15.7.2022
Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)
It allows the identification of specific devices on the market and facilitates their traceability.
15.7.2022