White Papers related to Medtech
White Paper
- July 12, 2021
Download our recent whitepaper to gain deep insights into when your notified body is losing its designation under the medical device regulation and how to effectively prepare for the change.
White Paper
- July 12, 2021
Download our recent whitepaper to gain deep insights into how to write an outstanding Clinical Overview.
White Paper
- July 7, 2021
Download our recent whitepaper to gain deep insights into the QMS aspects of the Medical Device Regulation.
White Paper
- July 7, 2021
Download our recent whitepaper to gain deep insights into the medical device regulations and their implications on device vigilance.
White Paper
- July 7, 2021
Download our recent whitepaper to gain deep insights into the new responsibilities for importers, distributors and authorized representatives for medical devices.
White Paper
- July 7, 2021
Download our recent whitepaper to gain deep insights into EU drug registration procedures.
White Paper
- June 14, 2021
Download our recent whitepaper which delivers deep insights about In vitro diagnostic medical devices regulation – summary of changes and impact for manufacturers.
White Paper
- June 14, 2021
Download our recent whitepaper which delivers deep insights about medical device software and mobile apps.
White Paper
- June 14, 2021
Download our recent whitepaper which helps you navigating the regulatory submission process for a class III medical device with ancillary medicine.
White Paper
- March 25, 2021
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.
White Paper
- September 10, 2020
This paper highlights what medical device manufacturers and other Economic Operators must be aware of ahead of the revised May 2021 deadline.
White Paper
- May 16, 2019
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.