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

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

This course provides a comprehensive overview of Australia’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Australia is utilizing MDSAP.   Read more

This course provides a comprehensive overview of Brazil’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Brazil is utilizing MDSAP. Read more

This course provides a comprehensive overview of Japan’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Japan is utilizing MDSAP. Read more