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.
EU Authorised Representative for Medical Devices
What an EU Authorised Representative does, when you need one, and how to choose the right partner under EU MDR.
How to Register Medical Devices in the UK
A comprehensive guide to UK medical device registration for UK and international manufacturers, including MHRA requirements.
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.
UK Responsible Person (UKRP) for Medical Devices
Everything manufacturers need to know about appointing a UK Responsible Person under UK medical device regulations.
Declaration of Conformity Template: UK and EU
Free declaration of conformity templates for UK and EU medical devices, with guidance on what each version requires.
What Is a Class 1 Medical Device?
An accessible explanation of Class 1 medical device classification under EU MDR, including registration and QMS requirements.
Internal Audit Report Template for ISO 13485
A practical internal audit reporting template for ISO 13485, with guidance on structure, findings and follow-up actions.
How to Identify the Legal Manufacturer for Medical Devices
A clear guide to identifying the legal manufacturer of a medical device under EU MDR and UK regulations.
Example Quality Objectives for ISO 13485
Practical examples of quality objectives for medical device manufacturers, aligned to ISO 13485 and MDR expectations.
Is ISO 13485 Required for CE Marking?
A clear answer on whether ISO 13485 certification is required for CE marking medical devices under EU MDR.
Quality & Regulatory Essentials for Medical Devices
Core quality and regulatory concepts every medical device professional should understand, explained clearly and practically.
EU Regulation 2024/1860 and Device Shortages
What EU Regulation 2024/1860 means for medical device availability and what manufacturers and economic operators should know.
Regulatory Compliance Strategy for EU MDR
A practical approach to building a regulatory compliance strategy under EU MDR, from classification to post-market obligations.
ISO 13485 Internal Audit Training Guide
Practical ISO 13485 internal audit training guidance. Understand what auditors look for and how to prepare your team.
Documents of External Origin: Do I Have to Revalidate?
A grounded look at when revalidation of external documents is required under ISO 13485 and what regulators expect.
UK Medical Devices Regulations: Latest Updates
The latest on UK medical device regulations, including MHRA timelines, transitional arrangements and what to act on now.
Cybersecurity within Medical Devices
An overview of cybersecurity requirements for medical devices under MDR and IEC 62304, and what manufacturers need to address.
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