This training will provide you with the latest information on the proposed alignment between QSR and ISO 13485. By attending, you can stay up to date with regulatory changes that may affect your organization's compliance requirements. It will provide insights into the similarities and differences between QSR and ISO 13485, helping you identify areas where your current compliance efforts can be aligned and streamlined.

By attending this training, you can gain a comprehensive understanding of the proposed changes, timelines, and implementation plans, enabling you to proactively prepare for the transition.

LEARNING OBJECTIVES

• Understanding ISO 13485: Participants will gain an in-depth understanding of the ISO 13485 standard, its key requirements, and its significance in the medical device industry. This objective aims to provide a solid foundation for comprehending the proposed alignment.
• Familiarity with FDA's Quality System Regulations (QSR): Participants will become familiar with the FDA's current regulatory framework for medical devices, including the key components and requirements of the QSR. This objective aims to highlight the existing differences between QSR and ISO 13485.
• Knowledge of the FDA's Proposal: Participants will gain knowledge about the FDA's formal proposal to align QSR with ISO 13485. They will understand the background, rationale, and key changes proposed by the FDA. This objective aims to provide insights into the potential impact of the alignment on medical device manufacturers.

AREAS COVERED

• Understanding ISO 13485
• Overview of FDA's Quality System Regulations (QSR)
• FDA's Proposal to Align QSR with ISO 13485
• Benefits of Aligning QSR with ISO 13485Challenges and Considerations
• Timeline and Implementation Plans

WHO WILL BENEFIT?

Cindy Williams

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