This course will give you a broad understanding of the quality management system requirements outlined in the medical device standard EN ISO 13485:2012 and 21 CFR 820. Content focuses on teaching the process approach for quality management and how EN ISO 13485:2012, EN ISO 14971:2012 (Risk Management Standard) and FDA’s Quality System requirements complement each other.
This 90 minute training is a valuable tool for any organization having to demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements, while serving as a guide to develop and maintain a robust quality system. Participants will have an opportunity to learn about industry best practices and pitfalls to avoid when implementing or maintaining a quality system.
Learning objectives include:
- Learn the elements of an effective quality management system to comply with ISO 13485 and 21 CFR 820 (FDA Requirements)
- Interpret all clauses of ISO 13485:2003 / EN ISO 13485:2012
- Understand notified body and enforcement agency expectations
- Understand the Quality System Management Review requirements
- Recognize the relationship between risk management, ISO 14971:2007 / EN ISO 14971:2012
- Learn to minimize risks while maximizing continuous improvement efforts
- Provide familiarity with the elements of a sound quality system
- Know how to prepare for an audit and effectively manage resources
- Understand the benefits of using problem solving tools to address CAPAs and audit findings
- Understand how to verify effectiveness of corrective actions, close out audit, and conduct follow-up surveillances