Design Controls
ISO 13485 Section 7.3 governs Design and Development controls for medical devices. The intent is to ensure that products are systematically designed, reviewed, verified, and validated before release. We help organizations build and execute design control programs that satisfy regulators and stand up under audit.
QMSR & ISO 13485 Design Controls — Key Stages
- Planning (7.3.2) — Define design phases, review/verification/validation activities, responsibilities, and interfaces between groups involved in design.
- Inputs (7.3.3) — Document functional, performance, regulatory, and safety requirements that the design must satisfy. Inputs must be reviewed for adequacy.
- Outputs (7.3.4) — Produce documented results (drawings, specs, procedures) that can be verified against inputs, including acceptance criteria and safety-critical characteristics.
- Review (7.3.5) — Conduct formal, planned reviews at defined stages to evaluate whether design results meet requirements and identify problems. Records must be maintained.
- Verification (7.3.6) — Confirm that design outputs meet design inputs, in other words, did we build it right. Must be documented with results and conclusions.
- Validation (7.3.7) — Confirm that the final device meets user needs and intended use under defined operating conditions, in other words, did we build the right thing. Includes clinical evaluation where applicable.
- Transfer (7.3.8) — Ensure design outputs are translated into production specifications before full manufacturing begins.
- Changes (7.3.9) — Any design changes must be identified, reviewed, verified or validated as appropriate, and approved before implementation.
- Design History File (DHF) — All of the above must be documented and maintained in a DHF, or equivalent record structure, to demonstrate compliance throughout the product lifecycle.
Why It Matters
The overarching goal is traceability, from user need to design input to design output to verification to validation, so that every requirement is demonstrably met before the device reaches the market. Gaps in design controls are among the most common and consequential FDA and Notified Body findings.
Who We Serve
We support medical device manufacturers building new products, transferring legacy designs, or remediating design history files in advance of audits, submissions, or due diligence reviews.
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