Overview

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Key Objectives and Content of a Periodic Safety Update Report (PSUR)
The Periodic Safety Update Report (PSUR) under the Medical Devices Regulation 2017/745 (
Nov 15, 2024
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
ISO 37001 versus ISO 37301 - Interview with auditor Hans-Jürgen Fengler
Should I implement an anti-corruption management system or a compliance management system? What are
Nov 05, 2024
# Compliance & Due Diligence
How to Improve Efficiency & Ensure Safety in Pharmaceutical Packaging Manufacturing
How Can You Improve Efficiency and Maximize Safety in Pharmaceutical Packaging Manufacturing? In the
Oct 31, 2024
# ISO 15378
Understanding Periodic Safety Update Reports (PSUR) for Medical Devices
Compliance with safety standards in the medical device industry is paramount. While the Medical Devi
Oct 24, 2024
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
Post-Market Surveillance and Vigilance: Requirements for MDSAP
In the rapidly evolving landscape of medical devices, ensuring patient safety and device
Sep 26, 2024
# MDSAP
Medical Device Approval Changes in Europe, USA, and Global Markets
The introduction of EU Regulation 2017/745, also known as the Medical Device Regulation (MDR), has f
Sep 20, 2024
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
# MDSAP
# ISO 13485

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