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ISO 14971 states that manufacturers shall establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks, and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is considered an integral part of a manufacturer’s QMS. This course presents the key foundations of the risk management process as defined in ISO 14971 and provide expert tips on how to navigate the process. Read More

This course has been reviewed for technical accuracy as of March 2019. All contents are validated to current requirements as of this date. Please note, some references such as transition dates have now passed since the making of this course. However,  NSF continues to provide this offering, as the technical content remains accurate and a necessary tool for the medical device industry.      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.   WHAT YOU GET A 90 minute video presentation from MDSAP recognized expert, Kim Trautman Competency assessment certification to add to your company’s training files (2 hours, including exam) 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 will examine the importance of a properly functioning complaint handling system. Once medical devices reach the market, clinicians and others may experience deficiencies related to the identity, quality, durability, reliability, safety, usability, effectiveness, or performance of the device.  These deficiencies may cause or contribute to a number of adverse events, including events that meet prescribed thresholds for adverse event reporting to regulatory authorities, including U.S. FDA Medical Device Reports (MDRs). This course will examine these reasons and help explain the important of a functioning complaint handling system and the relationship between complaints, service reports and CAPA. Note: Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.     Read More

Bundle of 5 Courses - Medical Devices Regulatory Requirements. 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 of ISO 13485:2016, the International Quality Management System Standard. Read More

A comprehensive overview of Australia's Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the Australian market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Australia is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard. Read More

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