Design Controls

QMSR & ISO 13485 Design Controls – High-Level Overview

ISO 13485 Section 7.3 governs Design and Development controls for medical devices. The intent is to ensure that products are systematically designed, verified, and validated before release.

Key stages and requirements:

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. Must include 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 (did we build it right?). Must be documented with results and conclusions.

Validation (7.3.7) — Confirm the final device meets user needs and intended use under defined operating conditions (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/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.

The overarching goal is traceability — from user need → design input → design output → verification → validation — so that every requirement is demonstrably met before the device reaches the market.