Design Controls
Design Control Compliance
Accurately performing and documenting design control is a crucial aspect of meeting 21 CFR Part 820 compliance requirements for medical device companies. ResearchDx can assist in all aspects of the Design control process including:
- Consulting services ensuring compliance to CFR Part 820.
- External compliance and pre-inspection audits
- Documentation development and review
- Comprehensive end-to-end implementation
Our Design Control Process | Our Design History File | Our Quality Process |
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Need Assistance, ResearchDx can help:
- Design and Development Planning and user needs assessments
- Design Inputs and Intended Use Requirements
- Design Outputs to ensure that all design inputs are met
- Design Review, and the documentation thereof
- Design Verification of all design inputs and outputs
- Design Validation of all initial production lots to ensure they meet intended use requirements
- Design Transfer, ensuring the device successfully moves from development to manufacturing
- Design Changes to ensure documentation of all validation, verification, review, and approval of design changes.
Schedule a consultation to learn more about Design Control Compliance.