Design & Development Control System (Clause 7.3)

Who This Kit Is For

Organisations needing a complete design and development control framework aligned with ISO 13485 clause 7.3.

The Compliance Problem It Solves

• Design controls distributed across several uncoordinated documents.
• Design history files that do not clearly evidence each required step and review.
• Unclear expectations for design inputs, outputs, verification, validation and transfer.

What You Get In This Kit

• Design and development SOP covering all 7.3 stages and design changes.
• DHF index, design plan, design review, design input/output, verification and validation templates.
• Design transfer and design change documentation forms.

How This Kit Reduces Your Audit Risk

• Creates a uniform, traceable design control framework across all projects.
• Ensures DHF content is consistent, complete and auditable.
• Improves alignment of design activities with risk management, PMS and regulatory submissions.

How To Implement It (Step-by-Step)

1. Download the system and customise stage-gate definitions and templates to your product lines.
2. Roll out the SOP and templates to all design teams and related functions.
3. Use the DHF index and forms for new and ongoing projects.
4. Periodically review design control performance and update processes as needed.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 clause 7.3; suitable for MDR/FDA design control requirements.
• Typical use: new product development and significant design changes.
• Document type: design & development control system.