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

This course bundle provides 6 eLearning courses, 16 hours of training in total, to prepare you and your team for FDA Medical Device Inspection.  Each course includes focused content developed by medical device experts experienced in conducting and managing FDA Inspections; knowledge checks throughout the course to keep the learner engaged; and a final competency assessment at the end of each course.  Individual Certificate of Successful Completion is provided for each of the 6 courses.  Courses in this bundle include: FDA Inspections of Medical Device Manufacturers FDA Medical Device Reporting Requirements  ISO 14971:2019 Application of Risk Management to Medical Devices Medical Device Complaint Handling and Servicing Design Controls for Medical Devices and IVDs U.S. Quality Systems & Combination Products- Practical Instruction Read More

In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary. The Quality System Inspection Technique, QSIT, is the primary tool used to conduct FDA inspections of medical device manufacturers.  QSIT is publicly available and will be the primary focus of this module. Read More

This course provides insight relative to the application of the Quality System Inspection Technique (QSIT). This course was developed by one of the original authors and life-long practitioner of QSIT.  Help prepare yourself for an FDA inspection by familiarizing yourself with the same inspection approach used by FDA investigators.   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