Every step in the process of developing an electronic medical device is subject to complex and specific rules and regulations. It is very different compared to developing a non-medical electronic product. Achieving certification requires compliance that extends way beyond product function. This has significant impact on engineering, manufacturing and business.
AllRound Technology has an extensive experience in developing and certifying medical devices according to the stringent European standards that are acknowledged globally. We are deeply committed to serving professionals in the medical industry to get their products to market, and ultimately helping patients.
We help our customers developing a consistent and effective quality management system, technical file, Intended use, interpretation of standards and regulations, formal risk analysis, and a retention system for certain critical documentation.