We have spoken frequently about the importance of Unique Device Identification (UDI) systems and their ability to improve traceability of medical devices throughout the supply chain to ensure patient safety. Our partners at Loftware share more about navigating global UDI systems and how they are “an integral part of streamlining regulatory processes.”
As mentioned above, traceability and patient safety are key factors in achieving UDI compliance. However, there’s a third critical factor: meeting all regulatory requirements. An integrated labeling solution that addresses these three factors will not only minimize disruption to production and business operations and, more importantly, ensure consumer safety.
- Traceability: Mislabeling is a leading cause of recalls and poses potential harm to patients, in addition to reputation and financial ruin to manufacturers.
- Patient Safety: Accurate labeling for both healthcare and patients is crucial. As wearable medical devices become more common and accessible to patients, ensuring that labeling has correct information, directions, and warnings becomes even more important.
- Meeting requirements: The need for manufacturers to be proactive regarding changing regulations is more relevant now than ever. The regulatory environment changes as new technologies come to market and incorporate UDI requirements into their labeling process to avoid delays, fines, and possible recalls.
By adopting a cloud-based labeling solution, many medical device manufacturers are experiencing the advantages of having a single data source, ensuring consistency and accuracy across all labels, and gaining access from any global location. This approach helps reduce the risk of errors and supports a “quality by design” strategy by integrating labeling into the product design and development process.
Pragmatyxs can assist manufacturers not only with Loftware’s Cloud solution’s compliance benefits but also by integrating it with their existing business systems for a seamless, efficient process.