Quality - SOP - Risk Management

Quality - SOP - Risk Management

$450.00 AUD

Effective risk management in medical devices development is critical for ensuring patient safety and regulatory compliance, as it helps identify and mitigate potential hazards throughout the product lifecycle. This document ensures your company complies with the mandatory ISO 14971:2019, ISO 24971:2020 risk management standard.

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Purpose of Document

This document defines the process and procedures for the identification, mitigation and management of risks throughout the product's life cycle.

Scope of Document/s

The document covers:

  • Risk analysis file structure, with key components
  • Risk management plan
  • Hazard analysis
  • Failure modes and effects analysis
  • Risk management report
  • Risk communication
  • Post-production and post market information.

The scope of this procedure covers ISO 14971:2019, ISO 24971:2020 and the FDA issued guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, which shall be available and used to direct all activities.

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