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.
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
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.
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.
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.
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.
Example Quality Objectives for ISO 13485
Practical examples of quality objectives for medical device manufacturers, aligned to ISO 13485 and MDR expectations.
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.
ISO 13485 Internal Audit Training Guide
Practical ISO 13485 internal audit training guidance. Understand what auditors look for and how to prepare your team.
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.
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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