Upcoming Sessions

Course Description: This virtual instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the upcoming European In vitro Diagnostic Regulations (EU IVDR).  The course describes the regulation for auditors and provides practical instruction for planning and conducting audits based on our EU IVDR Audit Model.  This course includes a two-hour eLearning prerequisite titled, “EU IVDR – A Comprehensive Overview” to be completed prior to the start of the live instruction. Students should have some internal audit experience, and ideally have lead auditor qualifications in QMS audits. Read More

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

Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection.  This course is designed to meet the needs of domestic and foreign medical device manufacturers doing business or intending to do business in the United States.  This course focuses on identifying and understanding FDA’s inspection criteria, resources (including key standard operating procedures such as CP 7382.845), and practices used to plan and conduct inspections of medical device manufacturers.  This course is designed to benefit your organization’s quality professionals responsible for managing and facilitating FDA inspections; as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.  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

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