Regulatory surveillance

The continuous updates of regulatory requirements, ISO/IEC standards and guidelines can be challenging to overview and prepare for.

We can help you with:

  • Surveillance of upcoming changes in relevant standards and regulations for your product types. Assess their impact.
  • Form the strategy for regulatory compliance as mandated by EU MDR & IVDR (Art. 10)
  • Support in interpretation of guidence documents
  • Adverse event and Vigilance reporting to Competent Authorities and the FDA
  • Planning and conducting Field Safety Corrective Actions and recalls

Contact me for further information
Nils-Åke Lindberg
Office +46 8 621 01 05 or send me an e-mail