Medical Device Country-Specific Regulatory Training

This instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.

This two-hour course provides a comprehensive overview of the regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way the U.S. is utilizing MDSAP.

This two-hour course provides a comprehensive overview of the regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Brazil is utilizing MDSAP.

This two-hour course provides a comprehensive overview of medical device regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Canada is utilizing MDSAP.

This two-hour course provides a comprehensive overview of regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Japan is utilizing MDSAP.

This two-hour course provides a comprehensive overview of medical device regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Australia is utilizing MDSAP.

This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements.

This two-hour self-paced course provides comprehensive instruction on the European Union Medical Device Regulation.

This two-hour course provides comprehensive instruction on the EU In Vitro Diagnostic Device Regulation.

This two-hour course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe.

This six-course bundle provides an overview of ISO 13485:2016 and the country-specific medical device regulatory requirements for the United States, Japan, Australia, Brazil and Canada.

This 10-hour course bundle provides a comprehensive overview of the medical device regulatory requirements for all five countries currently participating in the MDSAP program, a requirement for all manufacturers utilizing audits.

Today’s medical device auditor needs auditing skills, technical skills and up-to-date knowledge of the latest regulatory requirements. Meet these needs with NSF.

NSF’s training courses give you tools to ensure your product complies with international standards and regulations. Our diverse training programs teach you how to implement and apply global guidelines through all stages of the product lifecycle.

Understanding the legal and regulatory framework for developing, marketing and distributing medical devices can be challenging.