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The Medical Devices Postapproval Bundle links together three critical regulatory compliance activities following completion of the medical device product realization process --post market surveillance; post-release risk management; and corrections, removals and directed recalls. Intended for experienced regulatory, quality systems, medical affairs, legal, compliance management, and product development engineering personnel, this set of courses provide an examination of the applicable regulations, requirements and health authority reporting criteria across each of the three areas for the US, Canada and European Union.
Courses included in this bundle:
Medical Devices: Corrections, Removals and Directed Recalls
Examine compliance with US FDA (21 CFR §7, §806 and §810), Health Canada Medical Device Regulations (CMDR) and European Union medical devices directives (MDD, AIMDDand IVDD; and MEDDEV guidance). Definitions of the recall classification and type are explained together with the importance of the recall strategy, planning, communication, reporting and record keeping.
6–12 Hours | 6 RAC credits
Medical Devices: Postmarket Surveillance
Review requirements for an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe. The future of postmarket surveillance programs such as FDA's Postmarket Transformation Initiative and GHTF guidance is addressed.
4–8 Hours | 4 RAC credits
Medical Devices: Risk Management
Examine the management of risk as described in ISO 14971:2007, Medical Devices-The application of risk management to medical devicesusing specific examples. Topics addressed include management responsibilities, risk analysis and evaluation, risk controls and lifecycle risk management.
4–8 Hours | 4 RAC credits