Medical Device

A new level of customer attention, flexibility and reliability is brought to you by Crown CRO  from early regulatory consulting all the way to  medical device trials and CE-mark and 510(k) submissions.

Regulatory Strategy & Intelligence

  • Consultation on legislation and country specific requirements
  • Consultation on device classification and conformity assessment procedures
  • Regulatory advice on product development programs
  • Consultation and review of quality management systems (ISO 13485, QSR)
  • Liaison with regulatory bodies

Clinical Operations

  • Safety trials, CE-mark trials and Post marketing trials
  • Protocol development, site and country feasibilities and selection, regulatory submissions
  • Project management, monitoring, site management, data management, statistics, final reporting
  • Significant experience in various areas

Submission Management

  • Authoring and review of regulatory relevant documentation
  • CE mark applications  to NBs
  • 510(k) and PMA applications to the FDA
  • Post-approval changes and life-cycle management

Experience

  • Approximately 40 medical device trials
  • Indications include cardiovascular, CNS and orthopedic devices