Challenge A multinational healthcare company required their manufacturing units to go through a safety program as they were expanding their medical device innovation and capabilities to launch three new product lines.
Solution Developed a detailed digital & synchronous learning strategy and plan to execute the training for learners across the US, EU and APAC regions.
Results Developed and delivered eLearning and Instructor led modules on the regulations, processes and safety standards for clinical investigations and manufacturers of medical devices. This included the Foundational Course for Medical Devices, post-market periodic reporting, post-market medical device reporting and vigilance reporting, pre-market adverse event reporting, safety communications in clinical trials, and recall and corrective actions for medical devices.