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