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

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

On 02 February 2024 FDA announced in the Federal Register a final rule amending the device current good manufacturing practices (CGMPs) requirements codified within the Quality System Regulation, 21 CFR Part 820.  The amendment was undertaken to harmonize and modernize the regulation.  FDA is accomplishing this primarily by incorporating by reference the 2016 edition of ISO 13485 and part 3 of ISO 9000:2015. The amendment has resulted in the Quality Management System Regulation (QMSR). This training provides in-depth insight relative to the content and implementation of the new Quality Management System Regulation including: the purpose, scope and goals of the new regulation; the major provisions and changes associated with the new regulation; the effective date of the new regulation; a discussion of the term “incorporation by reference” (IBR); reference to guidance on the implementation of ISO 13485:2016 within a quality management system; rules for understanding which terms and definitions will be used; FDA’s policy for addressing changes to ancillary regulations, policies, etc. impacted by the new regulation; quality management system regulatory requirements beyond ISO 13485:2016; and, how changes to the CGMPs impact 21 CFR Part 4 Regulation of Combination Products. This training is essential to anyone involved in transitioning a quality management system to the requirements of the new Quality Management System Regulation; or anyone who works within an impacted quality management system.  Read more