Month: July 2021

bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning

July 12, 2021

bsi announced that it started public consultation for BS AAMI 34971 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning. The document is intended to provide… Read More

The IVDR and performance evaluation studies

July 8, 2021

by Michael Sander

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) is approaching quickly. As of May 26, 2022, all manufacturers of IVD medical devices will have to… Read More

New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR

July 4, 2021

by Oliver Giesemann

The Medical Device Coordination Group (MDCG) has issued another guidance document. MDCG 2021-10 references certain principles and terminology used in appendices E – I of the IMDRF N48 guidance document… Read More

Month: July 2021

bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning

The IVDR and performance evaluation studies

New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR

Supportive Information Section mdi Europa

Complete Download Section mdi Europa

Free intended use generator – an important tool under the MDR and IVDR