To expedite the Technical Documentation review process by the Notified Body and avoid extra costs and delays (which potentially could make your company miss the May 2024 deadline), your technical documentation submission needs to be right the first time!

Medical Device Software (MDSW) is a growing, fast-evolving industry. The purpose of this article is to address some of the most common (and not always right) assumptions and provide useful and truthful information about the process of reaching the conformity assessment under MDR, for successfully placing an MDSW on the market.

It is never too early in your project to start planning for sample size selection, considering its impact on your timelines, the cost of tests or the quality and quantity of representative devices to be produced to that end.