Tag Archives: Labeling

Warren Lesack

EU MDR: Ensuring Labeling Compliance

By Warren Lesack
No Comments
Warren Lesack

EU MDR requires significant reforms to the device labeling process. Manufacturers must ensure that identifiers are correctly applied to products, and that key data elements and formats are accurate. In addition, manufacturers need to have access to centralized data, audit tracking, robust security controls, eSignature capabilities and strong workflow management to ensure compliance.

Continue reading

Jack Cronenwett, MD
Reimbursement Report

How Real-World Evidence Helps Medical Device Manufacturers Drive Value

By Jack Cronenwett, MD
No Comments
Jack Cronenwett, MD

More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.

Continue reading

Bob Tilling, Kallik
MEDdesign

The Future Is Now: Digital Technologies that Are Revolutionizing the Medical Device Industry

By Bob Tilling
No Comments
Bob Tilling, Kallik

2022 is now upon us, hopefully marking the end of a very disruptive couple of years. Global challenges, from supply chain shortages to remote services, have driven digital innovation and change in the way we work across all sectors. The medical device industry is no different and going forward, having learned from the experiences of 2021.

Continue reading

Dave Locke, ACSYS
MEDdesign

Laser Automation and Robotics Support Medical Device Design Innovations

By David Locke
No Comments
Dave Locke, ACSYS

Automation handling with integrated controls can assist with laser marking for all shapes, sizes and materials used in the manufacture of medical devices. This approach can offer flexibility, along with the ultimate precision necessary, to support the UDI system, which provides a clear framework that defines the form in which information should be encoded on the device in accordance with its classification.

Continue reading