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Our services include:
Medical Device Registration (Offices in Australia, New Zealand, Asia & EU)
In-Country Regulatory Representation
ISO 13485 Medical Device Consulting and Implementation
ISO 13485/CE Marking/MDSAP Notified Body Quotations
Management System consulting (Quality/OH&S/Environmental)
Management System audits – internal/external/vendors (Quality/OH&S/Environmental)
Training
Testing – Medical Device + Cosmetics