Regulatory Support for Innovative Medical Devices

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.

How can we help?

With our company you can go through the whole process of introducing an innovative product to the market without any additional obstacles or problems, from the end of the design phase, through the selection of laboratories for testing, preparation of the necessary technical documentation, certification, and then notification or registration, which ends with the introduction of your innovative product to the market and making it available to future patients or users.