Risk Management Procedures Bundle | ISO 13485 | FDA QMSR

$499.00

Includes Related Forms
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Risk Management Procedure Bundle

The Risk Management Procedure Bundle includes four (4) Standard Operating Procedures and related Forms encapsulating the entire risk management process from product development through post-market feedback.

Risk Management Procedure Bundle - Content

The Risk Management Procedure Bundle includes the following risk management related procedures:

1) Risk Management Procedure

The Risk Management Procedure serves as the top level procedure governing design and production risk management, development of risk management plans, reports, and risk management files. The procedure includes multiple forms complete with helpful instruction.

2) Design Risk Management Procedure

The Design Risk Management Procedure provides detailed step by step guidance to help design teams properly identify design risks associated with the development of a medical device. The procedure includes multiple forms to capture the entire process in Excel format.

3) Process Risk Management Procedure

The Process Risk Management Procedure provides detailed step by step guidance to help design teams properly identify process risks associated with the production of a medical device. The procedure includes multiple forms to capture the entire process in Excel format.

4) Design Analysis Procedure

The Design Analysis Procedure includes detailed guidance on how to conduct DFMECA, PFMECA, House of Quality(HOQ) and Fault Tree Analysis(FTA). The procedure includes all related forms and ground rules for each study,

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.