Regulatory Affairs

Kasve can help you at the different stages of regulatory management.

Meet market reguirements

It takes huge effort and diverse competence to launch a medicinal or In Vitro Diagnostic device to the market. We have built a network around the competence of our specialists, bringing together extensive knowledge in solving various regulatory challenges, whether you are seeking to obtain a CE marking or FDA approval.

Kasve can help you at the different stages of regulatory management. We also actively utilise our comprehensive networks to always provide you with the best possible expert to meet your specific challenge.

Broad expertise at your service

We can help you with tasks such as:

  • Product classifications, defining purpose and mechanism
  • CE marking and FDA approval
  • Biocompatibility surveys
  • Use instructions and markings
  • Risk management
  • Required tests and trials
  • Usability planning and tests
  • Clinical assessment plan
  • Clinical validations for in-vitro diagnostics
  • Selecting and communicating with a Notified Body
  • Competitive tendering and validation of different vendors

Contact us

Nina Vartiainen

Head of QARA

Rosa Tengvall

Lead Quality Engineer

Do you need a qualified partner to support you?

We help healthtech companies succeed in the international market. Leverage our expertise and our comprehensive network!

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