In addition to providing an in-depth discussion of contemporary design and development principles and practices (and corresponding EU and FDA regulatory requirements), this approximately four-hour, self-paced course explores the essential relationships between risk management and design and development throughout the lifecycle of a medical device.  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

This course provides a greater understanding of the key requirements outlined in the EU MDR for medical device technical documentation. Learners will be able to conceptualize the regulatory requirements and the Notified Body expectation for technical documentation, helping to reduce unnecessary delays to the certification process. The content in this course supports the creation of compliant and Notified Body-friendly technical documentation. Read more

This course bundle provides 5 eLearning courses and 18 hours of training 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 to keep the learner engaged; and a final competency assessment at the end of each course.  An Individual Certificate of Successful Completion is provided for each of the 5 courses.  Courses in this bundle include: FDA Medical Device QS Regulation and Inspection Technique (QSIT) 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 Read more

This course provides insight on applying 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