Unique Device Identification is now a FD&C Act regulation. UDI has been used in healthcare for a number of years on a volunteer basis. Now it is required. It applies to all Medical Device classes, except for a number of GMP Exempt Class I devices.
Do you know the compliance deadlines?
Will your company meet the compliance dates established within this rule? Class III devices need to be compliant by September 24, 2014. Class II and Class I need to be compliant by September 2016 and September 2018 respectively. Download our timeline chart for your reference.
It will impact your entire company
There are many aspects of this new regulation that are confusing and complex. This is one regulation that will impact nearly every aspect of your company - from your Information Systems to Manufacturing to Quality and more.
UDI will become a worldwide standard
Whats more, the EU and other regulatory agencies worldwide are crafting their own UDI regulations. Will they be harmonized with the FDA version. We don't know at this time. We have the experience to help you, our partner, implement this regulation.
Improving Patient Safety is key
Postmarket surveillance and patient safety are a key reason why the UDI regulation was created.
- Reducing errors
- Improve adverse event reporting
- More thorough and complete recalls
- Adding device usage to Electronic
- And more...
We can help you implement UDI
RSQM has the experience and knowledge to help you implement UDI. From a one-day workshop that will give your staff a basic understanding of the UDI regulation and how to implement it, to complete project management including on going oversight needed to maintain your systems and the GUDID. Click here to learn more about the plans we offer to help you with become compliant.
Learn more about UDI
We will post relevant documents on our UDI Documents and on Our Blog pages to help you learn and educate your company on the importance of UDI.
We have the experience
RSQM has many years experience implementing unique identification systems - from UPC to GTINs. From project management to project design. From analysis to strategic planning. Contact us TODAY to help you implement UDI!
Unique Device Identifiers
This new regulation from FDA, was published September 24, 2013. It means a significant change in the way most medical device Labelers manage their products. And now the new EU MDR/IVDR regulations have been approved. Read below for more information...or check out our
UDI Documents page or Our Blogs to learn more about this important new regulation.
Looking implementation help? Review the services we provide that will help your company implement UDI.