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Mon

Jun, 23 2025

Why FMEA Differs from ISO 14971 in Medical Device Risk Management

Every medical device product (or process used to make medical devices) carries the risk of...

Tue

Apr, 22 2025

Co-existence of dFMEA and ISO 14971

Design FMEA (Failure Mode and Effects Analysis) and ISO 14971 are the most sought-after risk...

Wed

Feb, 10 2021

IEC 62366 – Usability Engineering for Medical Devices

Standards are necessary for the better functioning and regulation of different manufacturing and industrial sectors....

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MDR Guidelines

Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide

Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide

Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices

TÜV SÜD – Fact Sheet

MHRA – MDR – IVDR Guidance

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