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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

Bundle of 6 Courses - ISO 13485:2016 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. 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

Our ISO 17025 Testing and Calibration Laboratories eLearning course is designed to provide the learner with a thorough understanding of the ISO 17025 requirements and what they mean for you and your business as a crucial component to ensuring compliance and quality assurance.  Individuals involved in LMS (Laboratory Management Systems) activities should take this course to ensure the requirements of ISO 17025:2017 are understood by laboratory personnel and verify that an effective LMS is established.   This comprehensive 2 hr. course is focused on providing a detailed overview and breakdown of the key components of ISO 17025 for laboratory professionals engaged in the testing, calibration and/or sampling, specifying the following: Testing or calibration regarding competency and impartiality Selecting, verifying, and validating test methods Reporting results in an LMS. 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

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