Vincent Van Fulpen

6 articles

19 feb 2025 5 min

Vigilancia postcomercialización de productos sanitarios

Vigilancia postcomercialización de productos sanitarios - QbD Group

Quality Assurance18 feb 2025 3 min

Por qué las autoinspecciones son esenciales para tu QMS

Las autoinspecciones o auditorías internas son una parte esencial de tu QMS. Además de determinar si tu QMS cumple las directrices y normas, puedes beneficiarte de ellas de varias maneras. Te permiten conocer mejor los departamentos, explicar a las personas por qué son necesarios ciertos procesos...

Regulatory Affairs16 feb 2023 1 min

The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices

The European Parliament has adopted the proposed amendment to the MDR to extend the transitional period for legacy Medical Devices.

Quality Assurance5 jul 2022 3 min

Why self-inspections or internal audits are essential for your QMS

Self-inspections or internal audits are an essential part of your QMS. In addition to determining whether your QMS meets guidelines and standards, you can benefit from them in several ways. They allow you to get to know departments better, explain to people why certain quality processes are necessary, gather useful feedback for further improvements to the QMS, and you have a tool to check your readiness for external audits.

12 ago 2021 3 min

5 consequences of Brexit when selling medical devices in the UK

Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical devices on the UK market here.

16 dic 2020 4 min

Post-Market Surveillance of Medical Devices

A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical Device Directive (MDD) in May 2021.

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