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.
Team NB's Best Practice Guidance v3, Explained
What changed between v2 and v3 of Team NB's Best Practice Guidance for MDR technical documentation, and what it means for claims management.
How MDSAP Grading and Nonconformities Actually Work
How MDSAP's 7 chapters and nonconformity grading system work in practice, and where the programme sits relative to EU MDR.
Auditor Independence Under ISO 13485 Clause 8.2.4
What ISO 13485 clause 8.2.4 actually requires for auditor independence, and practical ways to demonstrate it in a small QMS.
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 Auditor Competency: How Much Is Enough?
Why training alone doesn't prove auditor competency under ISO 13485 clause 6.2, and what regulators actually expect to see.
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.
How to Make Internal Audits Work for You, Not Against You
How to build an ISO 13485 audit schedule under clause 8.2.4 that reflects real risk, instead of repeating the same audits every year.
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.
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