Medical Technology Ireland 2022
Read About the Economic Operators under MDR, IVDR in the EU!
22.9.2022
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
Manufacturers' guide to IVDR Update related to EUDAMED
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions
14.7.2022
Design Control (verification & validation)
For the end user's safety and to place the Medical Innovation on the market, a manufacturer has a legal obligation to maintain design control files.
12.7.2022
General Safety and Performance Requirements (GSPRs) checklist
Meaning of General Safety and Performance Requirements (GSPRs) and the checklist.
12.7.2022