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.
The Unique Risk Elements of ML enabled Medical Devices
How ISO 14971 risk management applies to AI and ML enabled devices, from BS/AAMI 34971 through to ISO/TR 24971-2 and post-market surveillance.
How AI Is Changing Leadership in Regulated Industries
A guest perspective on how AI is reshaping leadership, decision-making and accountability in regulated industries like MedTech.
Clinical Evaluation vs Clinical Investigation Under EU MDR
Why clinical evaluation is mandatory for every device under EU MDR Article 61, and when it actually triggers a clinical investigation.
How to Maintain Momentum After a Regulatory Submission
Why regulatory teams lose momentum after a submission, and practical strategies for keeping projects moving through the wait for feedback.
New EU MDR Notified Body Timelines, Explained
What the draft implementing regulation sets as maximum notified body timelines, plus the new Breakthrough Devices guidance under MDCG 2025-9.
6 Soft Skills Every Medical Device Auditor Needs
The soft skills, from communication to integrity, that separate an effective medical device auditor from a technically competent one.
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.
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.
What Makes a Supplier "Critical" Under MDSAP?
MDSAP is the only framework that formally defines a "critical supplier," and that definition changes how you should audit them.
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.
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