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Course Description: This virtual instructor led two-day course is highly interactive and includes practical instruction, case study exercises, and competency assessment. Provides an understanding of the risk management standard (ISO 14971:2019). This course includes a two-hour ISO 14971 overview module that must be completed prior to the start of the live instruction.  At the end of the course, you will understand how to: Evaluate the fundamental requirements of the medical device regulation relating to risk management Apply the ISO 14971 step-wise approach of risk identification, assessment, control and evaluation Know how to implement risk management within the product development, product manufacturing and postmarket phases of a product lifecycle Establish risk acceptability criteria Use risk management tools and activities for defining product characteristics to prepare risk management summaries for regulatory submission Understand the tools, techniques, information and records required to develop a successful risk management program and use as a basis for U.S. regulatory reviews This course includes a two-hour ISO 14971 overview module that must be completed prior to the start of the live instruction. Read More

Comprehensive regulatory requirements including the regulatory framework, pre and post market requirements, and instruction on the way Japan is utilizing MDSAP. Read More

This course provides the basic knowledge to prepare for the Medical Device Single Audit Program (MDSAP). It helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global quality systems expert, Kim Trautman. Learn about the MDSAP audit model, grading nonconformances and regulatory transition timelines, to name just a few highlights. Read More

Bundle of 6 Courses - Medical Device Single Audit Program (MDSAP) Overview and Country-Specific Medical Devices Regulatory Requirements for United States, Japan, Australia, Brazil, Canada A comprehensive overview of each countries' Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to market in each country and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how each country is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements. NSF International’s web-based virtual training course provides the basic knowledge to prepare for MDSAP, helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global Quality Systems expert, Kim Trautman, a former U.S. FDA official and key member of the original MDSAP development team. Kim also authored and led the implementation of the current U.S. FDA Quality System regulation and is a globally-recognized leader of continuing harmonization efforts for ISO 13485. Read More

Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and CAPA. It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard. Note: Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.     Read More

This course bundle provides comprehensive medical device regulatory requirements for all five countries currently utilizing MDSAP audits in their regulatory framework: Australia, Brazil, Canada, Japan and the United States. These five separate courses can also be purchased individually. Read More

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