Description:

This Design Control Pack groups procedure & templates to run phase-gated medical device design controls and keep the DHF audit-ready.

• Build a Design History File (DHF) index
• Capture User Requirements (UR) with acceptance criteria
• Convert UR into Design Inputs (DI)
• Plan verification/validation (V&V) with protocol/report evidence
• Document design reviews with an independent reviewer
• Complete design transfer to DMR/MDF and control design changes

Your needs:

• Implement a Design Control process with robust documentation ready and easy to use.
• Medical device design control pack for MDR decision-making and compliance to ISO 13485 requirements
• Reduce rework by aligning traceability, evidence, and phase-gate decisions.

Use this pack from feasibility through market launch to standardize design control records, especially when EU MDR (EU) 2017/745 and GSPR expectations apply.

Key requirements covered include objective decisions and consistent evidence. A phase gate is the documented go/no-go decision point, and a Traceability Matrix links UR/DI to outputs and V&V.

• Keep UR/DI clear and verifiable
• Define evidence-based acceptance criteria
• Record V&V results and deviations
• Check DHF completeness at reviews
• Assess change impact before release
• Confirm production readiness at transfer

Within Lexqara, we help structure your DHF, strengthen traceability, and prepare design reviews, V&V, and transfer readiness. Explore our Resource Center and Design Control Support for Start-Up Companies, plus EU MDR (Regulation (EU) 2017/745). Request a short gap assessment.