Adam Isaacs Rae 1/3/25 Adam Isaacs Rae 1/3/25 EU Authorised Representative Read More 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 Read More Adam Isaacs Rae 12/29/24 Adam Isaacs Rae 12/29/24 Understanding Medical Device Regulation in Turkey: A Comprehensive Guide Read More 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 Read More 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 Read More Adam Isaacs Rae 12/25/24 Adam Isaacs Rae 12/25/24 Declaration of Conformity Template UK and EU Read More Adam Isaacs Rae 12/25/24 Adam Isaacs Rae 12/25/24 What is a class 1 Medical Device? Read More Adam Isaacs Rae 9/11/24 Adam Isaacs Rae 9/11/24 Internal Audit Reporting Template Read More Adam Isaacs Rae 9/10/24 Adam Isaacs Rae 9/10/24 How to identify the legal manufacturer for medical devices Read More Adam Isaacs Rae 9/9/24 Adam Isaacs Rae 9/9/24 Example Quality Objectives Read More Adam Isaacs Rae 9/9/24 Adam Isaacs Rae 9/9/24 Is ISO 13485 Required for CE mark? Read More 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 Read More Adam Isaacs Rae 8/23/24 Adam Isaacs Rae 8/23/24 EU Regulation 2024/1860 and Device Shortages Read More Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24 Strategy for Regulatory Compliance MDR Read More Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24 ISO 13485 Internal Audit Training Read More Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24 Documents of External Origin: Do I have to revalidate? Read More Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24 What is the latest with the UK Medical Devices Regulations Read More Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24 Cybersecurity within Medical Devices Read More Adam Isaacs Rae 8/17/23 Adam Isaacs Rae 8/17/23 Review your Technical Documentation like a Notified Body (or UK Approved Body) Read More Adam Isaacs Rae 3/6/23 Adam Isaacs Rae 3/6/23 Commonly Misunderstood QMS Definitions: Correction, Corrective Action and Preventive Action Read More Older Posts
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 Read More
Adam Isaacs Rae 12/29/24 Adam Isaacs Rae 12/29/24 Understanding Medical Device Regulation in Turkey: A Comprehensive Guide Read More
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 Read More
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 Read More
Adam Isaacs Rae 12/25/24 Adam Isaacs Rae 12/25/24 Declaration of Conformity Template UK and EU Read More
Adam Isaacs Rae 9/10/24 Adam Isaacs Rae 9/10/24 How to identify the legal manufacturer for medical devices Read More
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 Read More
Adam Isaacs Rae 8/23/24 Adam Isaacs Rae 8/23/24 EU Regulation 2024/1860 and Device Shortages Read More
Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24 Documents of External Origin: Do I have to revalidate? Read More
Adam Isaacs Rae 8/20/24 Adam Isaacs Rae 8/20/24 What is the latest with the UK Medical Devices Regulations Read More
Adam Isaacs Rae 8/17/23 Adam Isaacs Rae 8/17/23 Review your Technical Documentation like a Notified Body (or UK Approved Body) Read More
Adam Isaacs Rae 3/6/23 Adam Isaacs Rae 3/6/23 Commonly Misunderstood QMS Definitions: Correction, Corrective Action and Preventive Action Read More
