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

摘要

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. 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. The approval process for something like a CE marking for a medical device can sometimes bog down the process of bringing a product to market. However; companies using a pre-submission evaluation for their technical file are achieving a quicker approval process and getting their products onto the market faster By having some regulatory guidance before finalising the technical file, a company can avoid having to wait weeks only to be told that their application contained avoidable omissions.