Virtual Medical Devices Training for Country-Specific Regulatory Requirements

  • Overview
  • eLearning Advantages
  • Learning Outcomes
  • Who Should Attend?

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 those differences and knowing how to comply with all the regulations.

This eLearning series of medical devices training courses covers country-specific requirements for Australia, Brazil, Canada, Japan and the United States. These computer-based courses offer highly interactive instruction on each jurisdiction’s legal and regulatory framework, premarket pathways and requirements, and postmarket regulations. The courses also introduce the Medical Device Single Audit Program (MDSAP) and highlight specific country requirements that must be considered for MDSAP audits.

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eLearning Advantages

NSF’s eLearning program offers the flexibility to learn at your own pace and schedule. Our flexible online modules are fun, interactive and available 24 hours a day, seven days a week. There are no worries about scheduling conflicts or costly travel expenses; the medical devices training modules offer all your learning needs with the click of a mouse.

Each highly interactive and engaging course in the series takes approximately 90 to 120 minutes to complete. The courses include knowledge checks and final assessments, resulting in a Certificate of Successful Completion, demonstrating objective evidence of competency. This objective evidence is a critical component of your company’s training files, as required under ISO 13485:2016.

Learning Outcomes

After completing the courses, you will be able to:

  • Identify the legal and regulatory framework for manufacturing, marketing and distributing medical devices
  • Distinguish how medical devices are classified
  • Learn about the Medical Device Single Audit Program (MDSAP) and its utilization in each country
  • Identify the premarket pathway and requirements for bringing a product or device to market in each country
  • Understand the postmarket requirements including quality audits requirements

Who Should Attend?

This medical devices training course is vital for any medical device professional looking to bring products to market, or to manufacture or audit products in a particular country or in all the MDSAP-participating countries. These courses are particularly helpful for employees responsible for regulatory compliance, including developing premarket submissions for entry into a particular country. Also, those interested in becoming a potential auditor under MDSAP should take these courses to demonstrate knowledge and competency in country-specific medical device requirements.

Upcoming Courses & Webinars

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