Medical Device Country-Specific Regulatory Training
Marketing a medical device in a global environment offers many challenges, as regulatory requirements vary widely from one country to another.
Bringing a product to market in multiple countries requires understanding regional differences and knowing how to comply with all regulations. Our training offerings include ISO standards courses.
Online Self-Paced Courses
United States - Medical Device Overview
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.
Brazil - Medical Device Overview
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.
Canada - Medical Device Overview
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.
Japan - Medical Device Overview
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.
Australia - Medical Device Overview
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.
China - Medical Device Overview
This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements.
Europe / EU MDR - Medical Device Overview
This two-hour self-paced course provides comprehensive instruction on the European Union Medical Device Regulation.
Europe / EU IVDR - In Vitro Device Overview
This two-hour course provides comprehensive instruction on the EU In Vitro Diagnostic Device Regulation.
ISO 13485: Medical Devices QMS - Requirements for Regulatory Purposes
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.
ISO 13485:2016 Overview and Country-Specific Medical Devices Regulations: Six-Course Bundle
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.
MDSAP Overview and Country-Specific Medical Device Regulations: Six-Course Bundle
This six-course bundle provides an overview of the Medical Device Single Audit Program (MDSAP) and country-specific medical device regulatory requirements for the United States, Japan, Australia, Brazil and Canada.
FDA Inspections of Medical Device Manufacturers
In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary.
Medical Device Regulatory Requirements: Five-Course MDSAP Bundle
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.
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Interested in Corporate In-House Training?
Don’t see what your team needs? We can deliver a broad range of medical device country-specific regulatory courses in a format that works for you and your team.
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