EU MDR & IVDR Insider

EU MDR & IVDR Insider | AKRA TEAM

Your monthly resource for EU MDR and IVDR compliance.

Tags: quality management system

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Medical Devices/ IVDs Post-Market Surveillance Going Toward Harmonization?

EU MDR & IVDR Insider November 2025 Special Issue A free publication from AKRA TEAM 👉🏻 Download the Full PDF Issue The paradigm shift from adverse event reporting to global safety monitoring. By Philippe Auclair, Ph.D. Regulatory Affairs Expert | AKRA TEAM ABSTRACT Harmonization efforts are ad...

by Philippe Auclair — Nov 26, 2025 device safety eu mdr eudamed ghtf ghwp global regulations imdrf ivdr medical devices paho pms quality management system real-world data regulatory affairs regulatory harmonization who

Enhancing Risk Management Throughout MedTech the Product Lifecycle

EU MDR & IVDR Insider October 2025 Issue A free publication from AKRA TEAM This issue explores how manufacturers can turn risk management from a compliance exercise into a connected, evolving system. Learn from Andrew Gibson (AKRA TEAM), Greg Griffin (BSI), and Arie Henkin (Omniscient Neurotechn...

Oct 31, 2025 compliance eu mdr iso 14971 ivdr lifecycle management medical devices pms qms quality management system regulatory affairs risk risk management