All of us in regulatory operations recognize the value UDI will bring to industry and patient safety. But with increasing regulatory requirements come additional tasks, that seem harder and harder to juggle while ensuring optimal market availability of our products.
You’ve probably underestimated the increasing responsibility and operational costs associated with meeting these global UDI requirements. The paradox of managing increasingly divergent and yet similar regional requirements of global UDI is challenging for us in the medical device industry to maintain compliance while increasing overall operational efficiencies. Although IT solutions are the key to compliance, organizations need the right regulatory strategy to ensure they can increase efficiencies and at a lower cost.
Health authorities around the world are creating device identification legislation regionally rather than globally. Several regional requirements are already in place and more will be implemented over the next few years, increasing the number and types of devices and the types of data they require for market authorization.
In this free webinar, our presenters will discuss the direct impact of UDI data requirements for multiple stakeholders and approaches considered across the industry to implement systems and processes. They will discuss the pros and cons of each — so you can make informed decisions as to what best suits your regulatory processes, product portfolio and market requirements.
Why UDI implementation is critical for industry and patient safety
Implications for manufacturers of increased visibility by regulators
Compliance timelines of various UDI initiatives underway around the world
How and why UDI is essential to regulatory affairs operational processes
How manufacturers can leverage UDI data to be better prepared for regulatory scrutiny while ensuring maximum market availability of their products
The individual stakeholders and who should be the true custodians of UDI data
How to leverage UDI data to drive internal regulatory intelligence
How organizations can mitigate potential challenges in regulatory data management for UDI compliance while reducing their operational costs
Get a better handle on Global UDI compliance in an increasingly complex environment. Join us by registering today for this free webinar.
Who Will Benefit
Regulatory affairs professionals
Quality assurance personnel