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Mayday Solution ApS is a danish, Regulatory Affairs & Quality Assurance consulting company. Mayday Solution ApS has the unique ability to assist medical devices companies with consulting services in connection with medical device development, approval, compliance and market access.

Mayday Solution ApS provides expertise in all aspects of the medical device life cycle, from idea to market introduction. Their support includes assistance with:

  • Developing a global regulatory strategy
  • Identifying the appropriate conformity assessment route (CE marking & 510(k))
  • Compliance with ISO 13485, FDA QSR incl. set-up and management of QMS
  • Establishing a risk management system
  • Structure of and review of Medical Device File / DHF and DMR
  • Performing internal and external audits
  • Post Market Surveillance activities
  • Liasing with Competent Authorities and Notified Body
  • Provide training and courses


jhgj@medicoindustrien.dks billede
Julie Husted