Services

Our services include:

  • Medical Device Registration (Offices in Australia, New Zealand, Asia, UK & EU)
  • In-Country Regulatory Representation
  • ISO 13485 Medical Device Consulting and Implementation
  • ISO 13485/CE Marking/MDSAP Notified Body Quotations
  • Training
  • Technical and medical writing documentation (Clinical Evaluation Reports, Usability Reports, Biocompatibility Reports, 510k submissions, MDR Technical Dossiers, TGA Conformity Assessment Dossiers etc) according to your product’s regulatory requirements.
  • Management System consulting (Quality/OH&S/Environmental)
  • Management System audits – internal/external/vendors (Quality/OH&S/Environmental)
  • Testing – Medical Device + Cosmetics