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 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.
Are Harmonised Standards Mandatory? MDCG 2021-5
MDCG 2021-5 Rev 1 confirms using a standard is voluntary, but notified bodies can still assess against one you haven't applied.
Mental Health Medical Devices: A Regulatory Overview
How digital mental health technologies fit existing medical device regulations, from borderline classification to risk management and clinical evidence.
MHRA International Recognition of Medical Devices and the AI Airlock
How the MHRA's international recognition framework and AI Airlock sandbox affect UK market access for AI-enabled devices.
Sterilisation Master File Template
A free sterilisation master file template for Class I medical device manufacturers, built around real regulatory expectations.
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.
Free Templates: Org Charts and Audit Checklists
Free templates for organisation charts and audit checklists, plus a look at the FDA's small business fee discount for 510(k) applications.
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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