Design Review Procedure | ISO 13485 | FDA QSR Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Design Review ProcedureThe Design Review Procedure establishes the systematic review of medical device development projects at logical points in the design and development process.
Design Review Procedure - OverviewThe Design Review Procedure is centered on the systematic review of new product design, extensions to existing lines, and design modifications requiring design control. Design Review Procedure includes review forms to document the entire review process.
Design Review Procedure - ComplianceThe Design Review Procedure is ISO 13485:2016, MDR 2017/745 and FDA 21 CFR Part 820 compliant.
To learn more about our Design Review Procedure contact us at [email protected]
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