Medical Devices & Diagnostics

Medical Device Registration, Approval Process, Classification, Listing, Consulting

AXSource Consulting provides medical device manufacturers, importers & distributors with establishment and licensing services (MDEL) to meet medical device regulations, including CE marking directives, in major jurisdictions.

We also provide Quality System development and implementation (ISO 13485, CE marking, IVDR or FDA QSRegulation) with registrar support from pre-audit or pre-inspection phase to final certification.

AXSource Consulting can also provide support in smooth transitioning and compliance to the MDSAP program. We have participated actively in government proceedings, joint conferences and trade associations, and have provided industry input.

AXSource consultants have licensed/registered over 120,000 hospital products, over 125 imaging products, software devices, IVDDs, combination products, and invasive devices with global regulatory authorities including Health Canada, FDA, EMA & TGA.