Over 20 years servicing the medical device industry

Obtaining regulatory approval to market a medical device is a pre-requisite for most medical devices. Our team of regulatory experts have vast experience in:

  • Preparing, submitting and obtaining approval of regulatory files for CE approval in Europe across all device classifications.
  • Preparing, submitting and obtaining approval/clearance for US Premarket Approvals (PMAs) and Premarket Notifications 510(k)s.
  • Obtaining regulatory approvals for all classes of medical devices in many geographies; Canada, Australia, Brazil, Japan, China and many more across Asia and the Middle East.
  • Interpretation of regulations and guidance documents and how to comply with your technical documentation.
  • Device labelling requirements and how to comply with them.