NSF Launches Online Training on Medical Device Regulations for MDSAP Countries

ANN ARBOR, Mich. – NSF is the first organization to launch 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 convenient training platform, and are structured in a consistent format to enhance the learning experience for regulatory compliance officers and auditors. Professionals and academicians may also find the training courses useful.

“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, Executive Vice President, Medical Device Training at NSF. “The NSF 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.”

NSF’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 competency of 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. Throughout each course, students will be reminded of the additions to the MDSAP audit model for that particular country. Competency assessments provide documented evidence for the training requirements of ISO 13485:2016, the international quality management system standard for medical devices.

The modules include:

• Medical Device Global Regulatory Requirements – Australia
• Medical Device Global Regulatory Requirements – Brazil
• Medical Device Global Regulatory Requirements – Canada
• Medical Device Global Regulatory Requirements – Japan
• Medical Device Global Regulatory Requirements – United States
• MDSAP Overview Training

Information and registration is available at NSF’s medical device e-Learning center.

NSF has also launched online training courses for professionals in the pharmaceutical/biotech industry. These include short, focused “how to” sessions on common industry themes as well as introductions and overviews on essential topics for industry newcomers.

For information about NSF’s online MDSAP training, contact Heather Howell, Executive Vice President, Medical Device Training, at hhowell@nsf.org, or +1.202-828-1594.

Editor’s Note: For media inquiries, please contact Thomas Frey, APR, at +1.734.214.6242 or email media@nsf.org.

NSF 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. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With operations in more than 175 countries, NSF is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.

NSF’s health sciences services include training and education, consulting, auditing, GMP and GLP analytical testing, DNA testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. NSF wrote the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.