Softreg GmbH (RegCheck)

- The time and cost of certification of a medical device can be longer / higher than the design and development of the product itself because most of the certification applications are submitted incomplete, and therefore not approved by the certification authorities. We accelerate the time-to-market of medical devices by generating automatic gap analysis, predicting the audit outcomes of their technical files, avoiding the lenghty refusal rounds.
- We can do it because we have the regulatory, and software expertise in house with our 3 members of the core team.
- There are 35000 MedTech companies providing more than 500'000 medical devices (with a constant 6% market growth) to the European market and 10000 certification applications each year.