Innovit Client Completes M2M Tests with AusUDID and EUDAMED
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...
Australian Unique Device Identification (UDI) Framework: Medical Device UDI Implementation, Essential Principles Guidance
Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements...
FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline
On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device Identification: Policy Regarding...