2025年2月19日 5 分钟
Vigilancia postcomercialización de productos sanitarios
Vigilancia postcomercialización de productos sanitarios - QbD Group
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Vincent Van Fulpen
6 articles
Quality Assurance2025年2月18日 3 分钟
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...
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Regulatory Affairs2023年2月16日 1 分钟
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.
阅读更多Quality Assurance2022年7月5日 3 分钟
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.
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2021年8月12日 3 分钟
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.
阅读更多2020年12月16日 4 分钟
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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