CLARIFYING UDI GREY AREAS IN THE UNITED STATES & BEYOND

  • On: September 23, 2015 at 09:09AM
  • Category: Conferences

Q1 Productions

Global UDI Intensive Workshop

 

Location: San Diego, CA

 

Throughout the medical device and diagnostic industries, organizations are currently looking to optimize and leverage investments made in the processes and technologies required to support compliant UDI practices. As many organizations have achieved compliance with FDA UDI standards, executives are now looking towards investments in order to identify areas where data can be leveraged to provide further value across the organization. Many executives are now looking towards international UDI regulations with an aim of streamlining processes and procedures on a global level in order to maintain robust compliance with evolving standards.

 

 

 

CLARIFYING UDI GREY AREAS IN THE UNITED STATES & BEYOND
As the medical device & diagnostic industries continue to comply with the FDA UDI Final Rule from September 2013, areas of uncertainty remain in requirements for the traceability of products throughout the entire life cycle. With compliance dates spreading over 5 years, labeling teams in charge of UDI aim to ensure newly developed processes are in-line with the FDA’s expectations to enable timely approval of products. Furthermore, medical device & diagnostic traceability rules are rapidly evolving, and UDI-specific regulations are developing across the globe adding to the challenge of building an internal strategy that meets current requirements and is flexible enough to soon incorporate requirements from Europe, Canada, APAC and more.

 

 

Presentation Main Points:

 

FDA UDI REGULATION REVIEW & CLARIFICATION

 

·         Review of the rule & ongoing implementation

 

·         Common implementation grey areas

 

·         Ensuring FDA compliant device & diagnostic marking

 

Helping clients be appropriately aggressive, yet compliant. TM