Medical Device Assessment
Medical devices to be used on the skin are chemically related to cosmetics. SkinConsult has know-how and experience regarding dermatology, chemistry, toxicology and cosmetics. This provides us with an excellent base from which to assess medical devices for the skin in terms of their safety. We conduct Medical Device Assessments for Class I and II medical devices. Our Medical Device Assessments are entirely scientifically grounded. We are familiar with European legislation regarding medical devices and with the advertising code of KOAG/KAG. [ Inspection Board for the Public Promotion of Medicines/Inspection Board for the Promotion of Health Products].
SkinConsult Medical Device Assessments:
- Contain an extensive toxicological Safety Assessment.
- Take the specific target group of the product into account.
- Evaluate beneficial effects with scientific substantiation.
- Explore complications based on literature.
For complete CE registration/Technical File, we work with Archy Consulting. Archy Consulting offers guidance and advice in the development of medical devices. Contact us to discuss the options that are available.