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.
Review Technical Docs Like a Notified Body
How to review your medical device technical documentation the way a notified body or UK approved body would assess it.
UK Medical Device PMS Requirements, Explained
What the UK's post-market surveillance regulations require, from PMS plans and reports to incident reporting timelines.
Correction, Corrective Action and CAPA Explained
Clear definitions of correction, corrective action and preventive action under ISO 13485, with practical examples for QMS teams.
Root Cause Analysis for Medical Devices
A practical guide to root cause analysis in medical device quality systems, including methods, documentation and common pitfalls.
UK and EU MDR Regulatory Changes, Late 2022
A round-up of UK MDR timeline changes, EU MDR Annex XVI common specifications, and staggered EU MDR transition deadlines from late 2022.
Quality Policy Statement Example for ISO 13485
A practical example of a quality policy statement for ISO 13485, with guidance on what to include and what to avoid.
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