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Course Description: This virtual instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the upcoming European Medical Device Regulations (EU MDR).  The course describes the regulation in depth from the auditor’s perspective and provides practical instruction for planning and conducting audits. This course includes a two-hour eLearning prerequisite module titled, “EU MDR – A Comprehensive Overview” to be completed prior to the start of the live instruction. Students should have some internal audit experience, and ideally have certified auditor / lead auditor qualifications in QMS audits. Read More

This course provides comprehensive instruction on the EU IVDR. It covers all aspects of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU IVDR, standard requirements that must be met by all IVD manufacturers, and pre- and post-market requirements of conformity assessment.​ Read More

This course provides comprehensive instruction on the EU MDR. It covers every aspect of the regulation and identifies key topics and changes, including economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.   Read More

The U.S. Medical Device Reporting regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers and device user facilities to report certain device-related adverse events and product problems to the FDA. This course provides critical information to ensure mandatory reporters maintain compliance with the regulation. Read More

The pre-submission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA. 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

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