ISO 13485 Design Controls & DHF Kit

A complete design control system for ISO 13485 clause 7.3 and FDA design control expectations: plan, inputs, outputs, reviews, verification, validation, transfer, change control and the design history file, with a fully worked example so you can see what finished records look like.

What's inside (39 files)

• Execution System: DC-SYS Design Controls Guide and SOP; DC-SYS Master Registers; DCH Design Change Control Pack; DCH Transfer and Change Trackers; DDP Design and Development Plan; DDP Plan Tracker; DI Design Inputs Matrices; DI Design Inputs Specification; DO Design Outputs Matrices; DO Design Outputs Specification; DR Design Review Action Log; DR Design Review Pack; DTR Design Transfer Pack; RM Risk Management Linkage Pack; RM Risk Traceability Matrix; VAL Validation Pack; VER Verification Pack; VV Verification and Validation Matrix.
• Additional Templates: Clinical Evaluation Report Template; DHF Audit Checklist; DHF Index; Feasibility and Concept Assessment; Lessons Learned Review; Regulatory Submission Cross-Reference; Software Development Lifecycle Plan; Usability and Human Factors Evaluation Record.
• Worked Example and Audit Defence: Audit Defence Index; Audit Failure Patterns and Test Scripts; Design Controls Audit Traps and Defences; Evidence Index and Traceability Closure Test; Worked Example - Blank Workbook; Worked Example - Filled Records; Worked Example - Filled Registers; Worked Example - Operating Manual.
• Training: Design Control training module (slides, trainer guide, workbook, assessment).

How to use it

1. Read the DC-SYS guide: it explains how the documents fit together from plan to transfer.
2. Start the Design and Development Plan and the plan tracker for your project.
3. Write design inputs, then outputs, keeping the trace matrices current as you go.
4. Hold design reviews at each stage with the review pack and action log.
5. Plan and record verification and validation, then transfer and control changes.
6. Check the DHF with the audit checklist and the audit defence index before your audit.

Who it's for

Manufacturers and design-only companies developing a device under ISO 13485 or FDA design controls.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Includes a Start Here guide with the contents and how to use them.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.
• Also in the ISO 13485 Complete QMS Kit, which costs less than buying kits separately.