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.
Medical Device Regulation in Turkey: A Complete Guide
A comprehensive guide to medical device regulation in Turkey, including registration, classification and compliance requirements.
FDA QMSR: Transitioning from QSR to ISO 13485
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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