First, the process and the requirements for the product are planned and a strategy for obtaining clinical data is developed. These data can be obtained via studies from scientific literature research or/and from clinical trials.
A medical device is used in or on humans and involves a certain degree of risk. In order to ensure a uniformly high level of protection, guidelines have been issued by the European Union and the FDA, among others. These guidelines govern the marketing and safe operation of medical devices.
This is associated with a large number of standards and legal requirements that must be observed by medical and pharmaceutical companies. We support you!
We provide consulting services for regulatory affairs, risk and quality management, usability engineering as well as in the areas of approval, classification and post-market surveillance.