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A practical guide to understanding why non-conformities happen, the most common issues in medical device submissions, and how to resolve them efficiently to get you back on track.
Dr Will Brambley
Lead Medical Writer
FDA approval alone is not sufficient for European market access - a theme we explore futher in this article and the accompanying webinar.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
This guest article from our partner Cyber Alchemy shows you how to build cybersecurity evidence for the EU MDR and NHS DTAC.
Luke Hill
Co-Founder of Cyber Alchemy
Cyber Alchemy × Mantra Systems — Episode 1: All three markets operate under different regulatory systems and place different demands on manufacturers.
Ronghe Xu
Regulatory Medical Writer & Strategic BD Lead China
Implementation of the EU MDR 2017/745 has brought significant changes.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
We're proud to join a this initiative supporting healthcare workers and patients to develop innovative solutions for the NHS.
Paul Hercock
Chief Executive Officer