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Different types of ISO 13485 Audits

Different types of ISO 13485 Audits

Audits are a key component of ISO 13485:2016

30.11.2022

EURLs IVDR

EURLs IVDR

What are EU Reference Laboratories under IVDR? EURLs

9.11.2022

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

ISO 13485:2016 – your partial gateway towards market entry around the World!

24.10.2022

Medical Technology Ireland 2022

Medical Technology Ireland 2022

Read About the Economic Operators under MDR, IVDR in the EU!

22.9.2022

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