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Risk Management Analysis (ISO 14971:2019)

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)

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)

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

What is CircaBC?

What is CircaBC?

The easiest way to share information in the European Commission

14.7.2022

Manufacturers' guide to IVDR Update related to EUDAMED

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)

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

Design File Compilation

Design File Compilation

Understanding the Design File and the process of compilation.

12.7.2022

General Safety and Performance Requirements (GSPRs) checklist

General Safety and Performance Requirements (GSPRs) checklist

Meaning of General Safety and Performance Requirements (GSPRs) and the checklist.

12.7.2022

What is EUDAMED

What is EUDAMED

EU-DA-MED
European Database on Medical Devices

7.7.2022