Design Controls

Design Controls is the medical-device-specific logical capability of running a documented, evidence-producing design process per 21 CFR 820.30 and ISO 13485 §7.3. It governs the loop from user need → design input → design output → verification → validation → transfer, with formal reviews at every stage and a change-control discipline overlaid on the whole flow.

What it covers

• Design plan — phases, deliverables, reviews, and resources.
• Design inputs — user needs and intended use translated into requirements.
• Design outputs — specifications and acceptance criteria for each input.
• Design verification and validation — does it meet inputs, and does it meet user needs?
• Design transfer to manufacturing, design reviews at gates, and design change control.

Relationships (see sidebar)

• Conforms to 21 CFR Part 820 §820.30 and ISO 13485 §7.3.
• Supports Detailed Design, Requirements Management, Regulatory Submission, and Quality Management.
• Implemented by medical-device PLM/ALM/QMS platforms including Aras Innovator (Design Controls app), PTC Arena (Arena QMS), PTC Codebeamer, and Siemens Polarion.
• Outputs feed into the Design History File and the Device Master Record.