Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.
Bob Tilling, VP of Global Sales at Kallik, delves into dupe culture and its link to counterfeit drugs, and explains how developments in label management can foil illicit traders.
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.
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.
The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.
“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
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.
Clinical Trials Labeling and Regulated Content Management Added to Cloud-Based Platform
Due to rapidly evolving regulatory landscape and manufacturing demands, label requirements and the information they contain are constantly changing. Here’s how medtech organizations can manage the process.
