This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard which serves as a basis for many medical device quality management system (QMS) regulations around the globe.  This course covers the goals of the standard and in-depth instruction regarding Clause 4-QMS; Clause 5-Management Responsibility; Clause 6-Resource Management; Clause 7-Product Realization; and Clause 8-Measurement Analysis and Improvement.  Read More

NSF International’s web-based virtual training course provides a basic understanding of Design Controls for medical devices and IVDs.  Providing knowledge to comply with US FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016, and the European Union Medical Device Regulation (EU MDR).  Learn from global Quality Systems expert, Kim Trautman, a former U.S. FDA official. Kim also authored the current U.S. FDA Quality System regulation and is a recognized leader of continued global regulatory harmonization efforts. What You Get A 2 hour video presentation from quality system expert, Kim Trautman Competency assessment certification to add to your company’s training files (2.5 hours, including exam) Read More

In 2017, the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746 was published, introducing major changes to the previous In Vitro Diagnostic Device Directive (IVDD 98/73/EC). Significant changes include changes associated with notified bodies, new risk classes based on a set of classification rules to determine conformity assessment requirements, reinforcement of rules on clinical evidence, strengthening of post market requirements and additional requirements for certain IVDs. To comply with the new EU IVDR, in vitro diagnostic medical device manufacturers must plan carefully to ensure the new requirements are fully understood and they identify appropriate resources for full implementation. This on-line course provides comprehensive instruction on the EU IVDR and walks learners through every aspect of the regulation, identifying key topics and changes. Read More

In 2017, the Medical Device Regulation (EU MDR) 2017/745 was published, introducing major changes to the previous Medical Device Directive (MDD). Significant changes include device classification, requirements for technical documentation, and clinical evidence, to name a few. To comply with the new EU MDR, medical device manufacturers must plan carefully to ensure the new requirements are fully understood and they identify appropriate resources for full implementation. This on-line computer-based learning course provides comprehensive instruction on the EU MDR. It walks students through every aspect of the regulation and identifying key topics and changes, including the new roles associated with EU MDR; standard requirements that must be met by all manufacturers regardless of class; and the requirements for conformity assessments. The module also provides pre- and post-market requirements of conformity assessment.   Read More

Medical Device Reporting is part of the Code of Federal Regulations - 21 CFR Part 803, mandated by Congress in 21 U.S.C. in 1976 to provide for federal oversight of medical devices.  It establishes the reporting requirements for not only manufacturers, but also importers and user facilities and is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving marketed medical devices.  It also helps to identify device problems that may be occurring across manufacturers and assists with trending analyses.  Medical Device Reporting provides a method for user facilities to inform FDA and the manufacturer about problems they are seeing and experiencing.  Medical Device Reporting is managed by the Center for Devices and Radiological Health (CDRH) at FDA. Other parts of the CFR interact with this portion of the regulation, including Part 806 - Corrections and Removals and part 820 - Good Manufacturing Practices. Read More

The Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. The idea behind the Q-Submission program is not new and in fact, has often been a critical part of premarket review. However, a comprehensive system for FDA feedback mechanisms had not been well-defined prior to FDA's recent guidance documents issued in 2017 and 2018. In this course we will review these guidance documents and the recommendations provided within to make your next request for FDA feedback more effective and productive. Read More

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