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Useful Tips for Devising a Clinical Development Plan

Useful Tips for Devising a Clinical Development Plan

A Clinical Development Plan is a defined strategy that maps out the expected method that is to be used for collecting relevant evidence and data of a sufficient level and quality for use in evaluating the performance and safety profile of a medical device as part of a...

Mexico medical device market 101

Mexico medical device market 101

Our Emerging market series continues! In previous Emerging markets articles, we looked in detail at some of the largest medical device markets, specifically Asia Pacific, Middle East, and Latin America and further analysed a selection of the markets in each region....

CER Reviews: Common Issues identified by Notified Bodies

CER Reviews: Common Issues identified by Notified Bodies

Clinical Evaluations are essential documents required within a Technical File for the successful submission to a Notified Body. They play a major role in achieving compliance with the regulations, and in gaining the ability to place a medical device on the market....