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.
Verification vs Validation, and Grandfather Rights
The difference between verification and validation in a QMS, and how grandfather rights justify retaining legacy suppliers or processes.
Meaningful KPIs and MDR Technical File Requirements
How to build KPIs that actually measure something useful, plus what MDR Annex II requires in your technical file and how to trace conformance.
Procedure Writing, Management Review and DXOs Explained
Practical guidance on writing QMS procedures, structuring management review, and controlling documents of external origin.
Privilege Management, SMART Objectives and Design Controls
Privilege Management, SMART Objectives and Design Controls
Information Classification, PESTLE and Privacy Policies
Free templates for information classification under ISO 27001, PESTLE analysis, and writing a privacy policy in plain, definitive language.
UK MDR Transition Periods, Audit Tips and Compliance Matrices
How UK MDR transition periods for CE and UKCA marked devices work, plus practical audit tips using opening meeting decks and compliance matrices.
Medical Device Audit Sampling: A Practical Guide
How to build a defensible, risk-based sampling methodology for medical device audits, covering judgement-based and statistical approaches.
PRRC Liability: What Happens If You Get It Wrong?
How PRRC liability actually works, including Italy's example of fines up to €120,000, and what it means for the person holding the role.
Should You Audit Your Own Technical Documentation?
Why auditing your technical documentation internally matters, even though your notified body reviews it too, and how to approach it.
System-Wide vs Focused Audits: Which Do You Need?
The difference between system-wide and focused internal audits, and how to decide which approach fits your QMS and risk profile.
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.
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