Medical Device Regulatory & Compliance Services
Our services include:
- Medical Device Registration (Offices in Australia, New Zealand, Asia, UK & EU), including ARTG inclusion
- In-Country Regulatory Representation, including acting as your Australian TGA sponsor
- 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, 510(k) 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