Digital Transformation May Be Key for Medical Device Compliance

Medical supply chain executives find regulatory compliance, and the associated complexity, increased administration, and bureaucracy a major hurdle. However, there is hope on the horizon for medical device manufacturers (MDMs) struggling to comply with UDI guidelines and other regulatory requirements governing the medical device industry. A Much-Needed Transformation in the Wings In order to keep up with the demands placed on it by regulatory entities, the medical device industry needs to transform itself. The transformation in question is a digital one. It involves taking all of the technological developments that have transformed other industries and applying them to every aspect of the medical device manufacturing process. We’ve seen a similar transformation in the pharma industry, where it has resulted in the total revamping of the pharmaceutical product supply infrastructure, from manufacturing to packaging and dispensing to patient delivery. If MDMs take a similar approach, the results will be nothing short of a revolution in the way they do business, including simplifying the road to regulatory compliance. This is a look at how a digital transformation impacts the medical device label production process and the related regulatory requirements. Goodbye Paper Offline catalogs are prevalent in the medical device industry. Paper-driven processes make compliance with regulations like the Unique Device Identification (UDI) system, 21 CFR Part 11 and the EU’s medical devi...
Source: MDDI - Category: Medical Devices Authors: Tags: Labeling Source Type: news