We Need Better Data to Make Better Decisions
Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.
Tag Archives: unique device identification
Big Data and Post Market Surveillance of Medical Devices
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.
EU MDR, UDI and Master Data: How to Ensure Label Compliance
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
UDI Implementation: Progress, Challenges, Where We Are Now
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
Keep Calm and Carry On… And Other Outlooks We Can Apply to MDR Implementation
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
Simplifying Medical Device Labeling in a Complex Environment
How simple labeling changes can drive big results for medical device manufacturers.
Truth in Labeling
FDA requires that manufactures establish and maintain procedures regarding labeling activities.
Preparing for UDI in Europe
The United States paves the way for seamless compliance.
FDA’s UDI Draft Guidance Aims to Help with Rule Compliance
The agency clarifies the UDI rule for labelers and accredited issuing agencies.
Eight Things You Need to Know about Unique Device Identification
Are you UDI-ready? Get the facts to achieve compliance fast.
