Technical innovation requires permanently adopted legal and regulatory requirements to achieve best quality for patients, users and third.


We implement different international regulations for medical devices and In-vitro-diagnostics and comply with a wide range of regulatory requirements in many international markets with a high degree of reliability.


Our services comply with requirements as manufacturer, supplier, specification developer and consultant.

Beside others we work according to:

  • Regulation 2017/745 (Medical Device Regulation)
  • EN ISO 13485:2016
  • 21 CFR Part 820
  • 21 CFR Part 11

According to your requirements an extension of regulations is possible. Contact us!