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Pre-submission technical file evaluation: a way to speed up your medical device time-to-market in the EU

This article was originally published in RAJ Devices

Executive Summary

One of the most well-known sayings in business is "time is money". The more time it takes for something to get done, the more money is wasted. Companies that can figure out a way to compress the time it takes for something to happen can realise significant cost savings and also get their products onto the market faster, beating the competition and increasing their market share. For manufacturers of medical devices in the EU, the part of getting a product to market that most often is blamed for slowing the whole process down – regulatory approval – may actually be one of these untapped areas for saving time and money.




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