Practical perspectives on medical device regulation

Insights to navigate regulation, bring medical technologies to market, and improve patient care.

Adam Isaacs Rae 1/3/25 Adam Isaacs Rae 1/3/25

EU Authorised Representative

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Adam Isaacs Rae 12/29/24 Adam Isaacs Rae 12/29/24

How to Register Medical Devices in the UK: A Comprehensive Guide for UK and International Manufacturers

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Adam Isaacs Rae 12/29/24 Adam Isaacs Rae 12/29/24

Understanding Medical Device Regulation in Turkey: A Comprehensive Guide

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Adam Isaacs Rae 12/29/24 Adam Isaacs Rae 12/29/24

FDA’s Final Rule on QMSR: Transitioning from QSR to ISO 13485-Aligned Quality Management

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Adam Isaacs Rae 12/25/24 Adam Isaacs Rae 12/25/24

Everything you need to know about UK Responsible Person (UKRP) for Medical Devices

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Adam Isaacs Rae 12/25/24 Adam Isaacs Rae 12/25/24

Declaration of Conformity Template UK and EU

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Adam Isaacs Rae 12/25/24 Adam Isaacs Rae 12/25/24

What is a class 1 Medical Device?

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Adam Isaacs Rae 9/11/24 Adam Isaacs Rae 9/11/24

Internal Audit Reporting Template

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Adam Isaacs Rae 9/10/24 Adam Isaacs Rae 9/10/24

How to identify the legal manufacturer for medical devices

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Adam Isaacs Rae 9/9/24 Adam Isaacs Rae 9/9/24

Example Quality Objectives

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Adam Isaacs Rae 9/9/24 Adam Isaacs Rae 9/9/24

Is ISO 13485 Required for CE mark?

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Adam Isaacs Rae 8/26/24 Adam Isaacs Rae 8/26/24

Quality & Regulatory Essentials

This is a list of my Quality and Regulatory Essentials as a Medical Device Regulatory Consultant

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Adam Isaacs Rae 8/23/24 Adam Isaacs Rae 8/23/24

EU Regulation 2024/1860 and Device Shortages

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Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24

Strategy for Regulatory Compliance MDR

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Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24

ISO 13485 Internal Audit Training

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Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24

Documents of External Origin: Do I have to revalidate?

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Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24

What is the latest with the UK Medical Devices Regulations

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Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24

Cybersecurity within Medical Devices

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Adam Isaacs Rae 8/17/23 Adam Isaacs Rae 8/17/23

Review your Technical Documentation like a Notified Body (or UK Approved Body)

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Adam Isaacs Rae 3/6/23 Adam Isaacs Rae 3/6/23

Commonly Misunderstood QMS Definitions: Correction, Corrective Action and Preventive Action

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