With Innovit’s expertise, our client achieved all goals and completed M2M tests with AusUDID and EUDAMED
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 realised 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. Thanks to Innovit’s expertise, our client was able to achieve all goals and complete M2M testing with AusUDID and EUDAMED.
And that’s something any medical device company can achieve with the right solution provider. Always ensure that the partners you choose fully understand the roadmap of the global environment to facilitate electronic data exchange with regulators and customers.
How Can Innovit Help You?
In today’s world of rapidly growing global compliance regulations, the only way to do business freely anywhere is to be compliant everywhere.
Medical device manufacturers looking to maintain and grow revenue must establish a strategic plan for developing compliance solutions and easily prepare data for submission to EUDAMED, AusUDID, GUDID, and other regulatory agencies.
We strongly recommend starting preparation early as this will ensure high standards for data quality and minimise the costs and risks associated with impulsive implementations.
With Australia, Brazil, and Saudi Arabia the next UDI hotspots, there are few options left to defer compliance. Specifically, while Saudi Arabia are not ready to support M2M data submissions, they do allow manual, file-based upload of UDI data, which means you can leverage an Innovit connector for this market despite not having M2M data exchange.
At Innovit, the leading provider of PIM solutions for regulatory data compliance, we have established dedicated teams of experts in IT that focus exclusively on medical devices and in vitro diagnostics. They communicate regularly with the EU Commission, US FDA, the Australian TGA, the Saudi FDA, and other regulatory agencies.
Not sure where to start on your path to Global UDI Compliance? We have resources to help.
- Download our Top 12 Things to Prepare for Your UDI Journey
- Join Us on Thursday, February 23 @ 11:00 CST for our Webinar: Top 12 Things to Prepare for your UDI Journey