Are you a manufacturer of an innovative medical device and would you like to quickly and effectively market a medical device?
The legal framework and standardised classification standards are based primarily on the risk assessment of the product. A specific conformity assessment procedure is carried out on this basis.
There is no doubt that innovative products require improved assessment to meet legal requirements and scientific evaluation in order to encourage innovation and ensure that patients have access to innovative, safe and effective medical devices. There is a widespread belief in the medical industry that the research and marketing of innovative medical devices progresses faster than issues relating to their evaluation methods and legal provisions. Given this fact, a very good knowledge of how to evaluate devices to meet technical and legal requirements is key to success.