Innovit is proud to announce that one of our clients, a global medical device company and leader in orthopedic devices, was the first to complete M2M testing with the TGA’s AusUDID – Australia’s regulatory database.
They are also one of the first companies to nail the end-to-end M2M EUDAMED testing.
We are pleased to see the fantastic results of our client’s tremendous efforts to ensure the continuity of healthcare in Australia and Europe by successfully testing for AusUDID and European MDR compliance.
Our client successfully met the more stringent regulatory requirements for medical devices, which aim to ensure patient safety further and increase confidence in product data quality.
Their Success Story
They realized early on that harmonizing master data across many regions would add cost and effort for medical device suppliers. It became clear to them that a medical device manufacturer needed a single source of truth to manage all these details effectively.
Their goal was to ensure that product data is:
- Aggregated from all the different sources of product information
- Validated against the targeted national regulatory requirements
- Checked for accuracy and consistency.
Our client needed to ensure that these crucial devices met global compliance requirements (e.g., 21 CFR Part 11, Annex 11, EUDAMED, AusUDID, GUDID, etc.).
They had to develop a comprehensive yet simple UDI data exchange strategy that was flexible, scalable, and ensured data quality and integrity. Working closely with Innovit, our client was able to achieve all goals and complete M2M testing with AusUDID and EUDAMED.
