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