NSF International is one of the first organisations to have 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 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.
Executive vice-president of medical device training at NSF International Heather Howell said: “Until now, professionals might find single courses for individual countries, often composed of brief videos and slides, but not nearly as in-depth, organised or consistent as this training series.
“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.”
NSF International’s new online programme 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 Australia, Brazil, Canada, Japan and the US.
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 utilises MDSAP. Throughout each course, students will be reminded of 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
NSF International 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.