This 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. This course covers the goals of the standard and detailed information regarding Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement. Read More

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 provides expert tips on how to navigate the process. Read More

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 4 Courses - Medical Device Single Audit Program (MDSAP) Overview and Country-Specific Medical Devices Regulatory Requirements for United States, Japan, and Brazil 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