Blog & Article
- 18th April 2024
White Papers related to Medtech
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Download our recent whitepaper to gain deep insights into how to write an outstanding Clinical Overview.
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Download our recent whitepaper to gain deep insights into the QMS aspects of the Medical Device Regulation.
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Download our recent whitepaper to gain deep insights into the medical device regulations and their implications on device vigilance.
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Download our recent whitepaper to gain deep insights into the new responsibilities for importers, distributors and authorized representatives for medical devices.
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Download our recent whitepaper to gain deep insights into EU drug registration procedures.
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Download our recent whitepaper which delivers deep insights about In vitro diagnostic medical devices regulation – summary of changes and impact for manufacturers.
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Download our recent whitepaper which delivers deep insights about medical device software and mobile apps.
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Download our recent whitepaper which helps you navigating the regulatory submission process for a class III medical device with ancillary medicine.
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This whitepaper summarises the key elements of MHRA’s guidance document on medical devices, regarding registration, assessment procedures, labeling, post-market surveillance, and vigilance that will apply for devices placed on the market in Great Britain (England, Wales, and Scotland) and Northern Ireland. This document provides a list of actions that manufacturers of medical devices should take in order to continue the placement of their products on the EU and UK markets.
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This paper highlights what medical device manufacturers and other Economic Operators must be aware of ahead of the revised May 2021 deadline.
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This paper highlights just a few key points that need consideration ahead of the new Medical Device Regulation 2017/745 (MDR) being implemented in 26th May 2020.