Regulatory Assistance

Government Regulation is a very important component of a CROs work. Regulatory compliance is one of the top issues that medical device firms face today. KasaConsult offers a broad range of services to assist its customers with regulatory requirements:

  • Selection of and assistance with conformity assessment procedures
  • Guidance with CE marking
  • Spearheading some portions of the risk analysis
  • Dialogue with notified bodies, competent authorities and EU commission