Design Analysis Procedure | ISO 13485 | FDA QSR Compliant
The Design Analysis Procedure includes detailed guidance on how to conduct DFMECA, PFMECA, House of Quality(HOQ) and Fault Tree Analysis(FTA). The Design Analysis Procedure is ISO 14971:2019 and ISO 13485:2016 compliant and includes all related forms and the ground rules for each study type.
- ISO 14971:2019 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Design Analysis ProcedureThe Design Analysis Procedure is used in conjunction with the company's risk management policies applicable to the development of new products and processes; and for significant changes to existing products or processes.
ISO Design Analysis Procedure OverviewThe 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,
The Design Analysis Procedure is used during product development, design verification and validation activity, and helps design teams to assess and mitigate the individual and overall risk of products and related processes.
ISO 13485 Design Analysis Procedure ComplianceThe ISO 13485 Design Analysis Procedure is ISO 14971:2019, FDA 21 CFR Part 820 and ISO 13485:2016 compliant.
To learn more about our ISO 13485 Design Analysis Procedure contact us at [email protected]
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