In business there’s a saying: 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 realize significant cost savings and also get their products into the market faster, beating the competition and increasing their market share. For manufacturers of medical devices, 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 found time and money.

There’s no doubt about the fact that the approval process for something like the CE marking for a medical device can sometimes bog down the process of bringing a product to market. However, companies using a presubmission evaluation for their technical file are realizing a quicker approval process and getting their products into the market faster. By having some regulatory guidance before finalizing the technical file, a company can easily avoid having to wait weeks only to be told that their application contained avoidable omissions.

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