Design Control Pack
Design control template
Design Control Pack for medical device design controls
Use this editable Design Control to run phase-gated design controls, keep your Design History File (DHF) complete, and demonstrate that your device was developed under controlled requirements.
- Best for: DHF management, design planning, V&V evidence capture, design review and change control.
- Includes: editable sections for inputs, outputs, planning, reviews, transfer, changes and V&V records.
- Format: editable template available through the standard WooCommerce download flow.
Lexqara helps medical device manufacturers build robust design controls that satisfy both FDA QSR and EU MDR requirements. Explore the Resource Center or review our Design Control Services.
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.
Free design control resource
What the Design Control Pack helps you structure
This pack provides a practical structure for documenting medical device design controls from feasibility through design transfer and change control. It is intended for teams building or strengthening a Design History File (DHF) under ISO 13485 and EU MDR expectations.
Use it to support
- Design History File (DHF) organisation
- User requirements and acceptance criteria
- Design inputs and design outputs
- Design verification and validation evidence
- Design reviews and independent review records
- Design transfer and design change control
Free