Design controls templates that link together
User needs, requirements, traceability, and risk files for medical device startups, students, and first-time founders. Every ID connects to the next, so nothing gets lost between documents.
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Illustrative example. The templates create IDs automatically and use dropdowns to link each level.
Built for people new to design controls
Students and university groups
Creative teams who haven't been taught design controls get a clear structure they can use in capstone and senior design projects.
Startups
Start your design history file on solid footing, before an investor, partner, or reviewer asks for it.
People with an idea
See what a medical device project needs from concept to submission, and plan it before you spend on development.
What's in the first template pack
- Design Controls Starter Kit with automatic IDs, linked dropdowns, a traceability matrix, and a Chain View from inputs to outputs
- Risk Management Toolkit with FMEA, use-related risk analysis, cause-mitigation table, and risk control matrix, with synced block diagram and P-diagram tables
- DHF and 510(k) eSTAR Map covering 36 DHF documents and 22 eSTAR sections
- EU MDR Technical Documentation Map covering 32 items plus 16 EU-only documents
- Regulatory Standards and Region Hold Tracker for 13 regions, with a ship gate and rollout timeline
- QMS Document Tracker with 68 documents, scope, status, and review flags
- Guide and Data Map showing how every document connects, inputs to outputs
Coming next: a free lite kit, an instructor kit with slides and rubric, a worked example project, and Word templates for plans, protocols, and design reviews.
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Tell us where to send your free one-page guide and launch pricing.
Questions? Email us at hello@devicereadyresources.com.