Ann Arbor, Mich.-based NSF International has launched a comprehensive set of online training modules covering global medical device regulatory requirements for all five countries participating in the Medical Device Single Audit Program (MDSAP). The modules bring together the regulatory requirements in a comprehensive training platform, and are structured to enhance the learning experience for regulatory compliance officers and auditors, NSF International officials say.
“Until now, professionals might find single courses for individual countries, often composed of brief videos and slides, but not nearly as in depth, organized or consistent as this training series,” says Heather Howell, executive vice president, medical device training at NSF International. “The NSF International modules are interactive, and our customers are very excited to have this level of information, particularly for countries such as Japan, Brazil, and Australia.”
NSF International’s new online program includes interactive training, tools, and video-based courses. When a course is successfully completed, the attendee receives a certificate, which can be used to verify MDSAP competency in the five participating nations: Australia, Brazil, Canada, Japan, and the United States.
The training modules offer a comprehensive overview of each country’s medical device regulatory framework, including both premarket and post-market requirements, an introduction to MDSAP and how each country utilizes MDSAP. Each course includes special instructions for applying the MDSAP audit model to a particular country. Competency assessments provide documented evidence for the training requirements of ISO 13485:2016, the international quality management system standard for medical devices.
For more information regarding the MDSAP, read this exclusive 24×7 Magazine article.