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About This Item


Full Description


Describes procedures for performing, documenting, approving, and archiving a risk analysis. Applicable to medical devices manufactured and/or distributed for use in clinical trials, placed on the market, or put into service. Covers the general process, harm, risk reduction measures, probably and severity estimation, risk hazard evaluation, risk analysis reports, approval and archiving, and followup review activities. Includes provisions for compliance with MDD 93/42/EEC, EN 1441, ISO/DIS 14871, EN 1050, IEC 0125, IEC 812:1985, and PrEN 12442-1,2,3.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Example of Risk Graph, Risk Analysis Table, Risk Assessment Process Flow Diagram

About This Document:

This is not a generic template, it's a 8-page procedure that was actually created and used in the Device Engineering operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

  • Use it as a starting point for your own documentation project
  • Compare the quality of your documents against your industry peers
  • Learn what other companies in your industry are actually doing

Who Will Benefit:

  • Engineering Managers
  • Quality Assurance Managers
  • Engineering Development & Manufacturing Personnel

Document History

  1. DOXPUB 09-0224-SOP


    Risk Analysis

    • Most Recent
  2. DOXPUB 09-0224-SOP-1.0

    Medical Device Risk Analysis

    • Historical Version