Medical Device Assessments

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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.

Need Medical Device Assessments?

Do you have medical devices for skin application for which you require a safety assessment? Contact us to discuss the options that are available.

How is a Medical Device Assessment conducted?

A Medical Device Assessment consists of a toxicological Safety Assessment and a product review based on the academic literature. In the Safety Assessment, a toxicological profile is compiled for each of the product’s ingredients. The Margin of Safety (MoS) values are calculated per ingredient for normal and excessive use. The MoS values are used to determine whether it is safe to use the product. The entire product is scrutinized during the product review. The beneficial effects and possible complications of using the product are established, based on the academic literature. In doing so, the pathological features of the target group are explicitly taken into account.