Manufacturing

A flood of medical device recalls and scathing reports by US oversight agencies has given notice to the industry that they are to be held to a more demanding standard for product quality by the FDA. Internationally, the same message has been sent by the European Union and member countries, ICH, WHO and national governments including Germany, Japan and the United Kingdom. Increased inspection of medical device manufacturing facilities, escalating scrutiny of suppliers and an expansion of regulatory requirements has set the stage for heightened risks of compliance violations for medical device companies.

UL provides multi-pronged compliance solutions to companies in the medical device industry, regardless of the location of the companies or their suppliers.

• Our online courses are authored and reviewed by the FDA and AdvaMed to comply with FDA’s most current compliance requirements.
• Additional curricula address the cGMP compliance needs of non-US companies and suppliers including those based in the EMEA.
• Our robust learning management system, ComplianceWire, generates, distributes, tracks and documents regulatory training, on-the-job skills and SOP training, corporate policies and procedures, and the compliance activities of employees, remote suppliers and subcontractors. Compliance leverages the Cloud-based Computing model, which stores documentation in a secure data center and minimizes burdens on the company’s IT and management resources.
• UL’s blended learning solutions provide the unique advantages of online, computer-based and instructor-led training to drive knowledge and maintain compliance and efficiencies.