NSF International’s web-based virtual training course provides a basic understanding of Design Controls for medical devices and IVDs.  Providing knowledge to comply with US FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016, and the European Union Medical Device Regulation (EU MDR).  Learn from global Quality Systems expert, Kim Trautman, a former U.S. FDA official. Kim also authored the current U.S. FDA Quality System regulation and is a recognized leader of continued global regulatory harmonization efforts. What You Get A 2 hour video presentation from quality system expert, Kim Trautman Competency assessment certification to add to your company’s training files (2.5 hours, including exam) Read More

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 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

A comprehensive overview of Brazil's Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the Brazilian market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Brazil 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 Canada's Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the Canadian market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Canada 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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