Practical perspectives on medical device regulation
Insights to navigate regulation, bring medical technologies to market, and improve patient care.
EU Authorised Representative
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.
Understanding Medical Device Regulation in Turkey: A Comprehensive Guide
This guide provides an in-depth overview of Turkey's medical device regulations, insights into importing and exporting devices, and references to trade agreements with key global markets, including the EU, UK, USA, and Canada.
FDA’s Final Rule on QMSR: Transitioning from QSR to ISO 13485-Aligned Quality Management
A comprehensive overview of QMSR, its alignment with ISO 13485, the role of consensus recognised standards, and actionable strategies for manufacturers to prepare for compliance.
Cybersecurity within Medical Devices
Using the "Swiss cheese" layers of defence model, this post breaks down how cybersecurity risk should be built into medical device design, from security policies through to penetration testing, in line with EU MDR information security requirements.
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