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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...

Fri

Apr, 23 2021

EU MDR 2017/745: Periodic Safety Update Report (PSUR)

The preparation of a Periodic Safety Update Report (PSUR) by medical device manufacturers is amongst...

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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

Worldwide regulation resources

USA Regulatory Framework Medical Device registration

Taiwan Regulatory Framework Medical Device registration

South Korea Regulatory Framework Medical Device registration

South Africa Regulatory Framework Medical Device registration

Singapore Regulatory Framework Medical Device registration

Saudi Arabia Regulatory Framework Medical Device registration

Russia Regulatory Framework Medical Device registration

Peru Regulatory Framework Medical Device registration

New Zealand Regulatory Framework Medical Device registration

Mexico Regulatory Framework Medical Device registration

Malaysia Regulatory Framework Medical Device registration

India Regulatory Framework Medical Device registration

Hong Kong Regulatory Framework Medical Device registration

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