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UK PMS Regulations for Medical Devices: Part 3 – UK PMS Regulations vs. EU MDR
Key Differences and Impact on CE-Marked Devices in Great BritainIn PART I – Overview and Key Requi
Mar 20, 2025
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
UK PMS Regulations for Medical Devices: Part 2 – Vigilance & Reporting Requirements
In PART I – Overview & Key Requirements of the UK PMS System for Medical Devices, we explored the
Mar 20, 2025
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
UK PMS Regulations for Medical Devices: Part 1 – Overview & Key Requirements
The new UK Post-Market Surveillance (PMS) regulations, introduced through the Medical Devices (Post-
Mar 19, 2025
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
Understanding ISO 13485: Excluded Clauses vs. Not Applicable Clauses
ISO 13485 is an international standard that sets the requirements for a quality management system (Q
Mar 18, 2025
# ISO 13485
Revision of ISO 14001 in sight
In April 2023, ISO published its results of the second User Survey on ISO 14001. The survey was orga
Feb 28, 2025
# Environmental management
Fit for digitization: three strengths of quality management
How can quality management (QM) face up to the changes brought about by digitization in order to rem
Feb 27, 2025
# Digitalization in Quality Management

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