Jonathan C. Bretz, OT/L, MBA, RAC is a UDI Consultant, and has 35+ years medical device experience, including Regulatory Affairs/Compliance, Submission experience [510(k), CE Technical Files, Health Canada], Quality Systems (QSR, ISO 13485), Risk Mitigation (ISO 14971), Regulatory Strategies, UDI/GTINs, Product Development, Marketing & Sales, Operations and Supply Chain Management. Jon can be contacted at 617-356-7776, or email@example.com
His webinar, “FDA UDI Regulation Impact on Medical Device Labelers“ is an information resource.
FDA UDI Regulation Impact on Medical Device Labelers Webinar excerpt: “The FDA UDI Regulation Impact on Medical Device Labelers webinar presented by subject matter expert, Jonathan Bretz, provides specific recommendations and a 3-Step Plan of how to plan for, implement and follow through to meet the requirements of this new regulation, its global impact, benefits, definitions, key compliance timelines (September 24, 2014 for Class III/PHS Act devices) and why this is a “publish or perish” regulation.
“The most important reason for UDI regulations is the need to improve the accuracy and timeliness of Post-Market Surveillance (PMS) data. More accurate and timely PMS data will indirectly improve patient safety by helping facilitate more accurate reporting, reviewing and analyzing of adverse event reports, so problem devices can be pinpointed, corrected and removed faster.” -Jon Bretz, What is UDI and Why It Matters