Description:

This procedure sets how we plan, run, review, and document design controls from feasibility to market launch.
• Establish and maintain the Design History File (DHF) using a controlled index.
• Use a phase-gated model with formal design reviews at each phase.
• Capture and approve customer requirements and design inputs with measurable acceptance criteria.
• Generate controlled design outputs (incl. labeling/IFU and software deliverables where applicable).
• Execute design verification and design validation with protocol/report evidence and traceability.
• Perform design transfer ensuring production readiness via DMR/MDF alignment.
• Control pre-market design change through impact assessment, actions, and DHF transfer.

Your needs:

• medical device design control aligned with ISO 13485 requirements
• medical device design control for MDR decision-making
• Reduce rework and audit risk with clear phase-gate evidence.

Use this procedure at project initiation and throughout development to keep design planning, traceability matrix updates, and verification/validation aligned with MDR (EU) 2017/745 expectations, including GSPR considerations.

Key requirements include defined records and decisions. The DHF is the controlled record set proving design activities were performed as planned, and a Traceability Matrix links requirements to outputs and V&V evidence.
• Maintain DHF completeness checks at design reviews and before transfer.
• Freeze approved design inputs and control subsequent changes.
• Ensure V&V protocols/reports document deviations and conclusions.
• Confirm independent participation in design reviews and transfer.
• Keep design outputs production-ready for routine inspection and release.

Within Lexqara, we support regulatory strategy, QMS implementation, design support, audits, and training to operationalize design controls. Explore our Resource Center and Design Control Support for Start-up Companies, and consult EU MDR (Regulation (EU) 2017/745). Request a short gap assessment.