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.
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.
What Is a Class 1 Medical Device?
An accessible explanation of Class 1 medical device classification under EU MDR, including registration and QMS requirements.
How to Identify the Legal Manufacturer for Medical Devices
A clear guide to identifying the legal manufacturer of a medical device under EU MDR and UK regulations.
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.
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.
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