The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory compliance officers and auditors involved with regulatory processes working in the medical device industry in the five countries participating in Medical Device Single Audit Program (MDSAP). (published site)
The online courses include quality management systems (QMS) auditing, 510(k) premarket notification, and country-specific medical device regulatory requirements.
NSF International is the first organization to launch a series of online training modules covering global device regulatory requirement for all five countries participating in the Medical Device Single Audit Program (MDSAP).
NSF International is an independent, global organization that writes standards and tests and certifies products for the health sciences, food, water, and consumer goods industries to minimize adverse health effects and protect the environment.
“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,” said Heather Howell in a press release. Howell serves as Executive Vice President, Medical Device Training at NSF International. “The NSF International modules are fun and interactive, and our customers are very excited to have this level of information, particularly for countries such as Japan, Brazil and Australia.”
The courses include interactive training, tools, and video-based courses that users can complete at their own pace. Participants successfully completing a course receive a certificate that verifies competency for the five MDSAP nations (Australia, Brazil, Canada, Japan, and the US).
The courses provide a comprehensive MDSAP overview of the medical device regulatory framework in each country, and pre- and post-market requirements, and an introduction to the MDSAP audit model for each country.
Testing for competency provides documentation for the training requirements of ISO 13485:2016, the international quality management system standard for medical devices.
Information and registration is available at NSF International’s medical device e-Learning center. For information about NSF International’s online MDSAP training, contact Heather Howell, Executive Vice President, Medical Device Training, at hhowell@nsf.org, or +1.202-828-1594.
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Source: press materials provided by NSF International
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