$247 — Standard Tier

Design Controls Toolkit: FDA 820.30 & ISO 13485 Procedure Templates

Complete design controls toolkit with design input, output, verification, validation, and DHF templates. Meet FDA 21 CFR 820.30 and ISO 13485 requirements.

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What's Included

Design Control Procedure (SOP)
Design & Development Plan Template
Design Input Requirements Template
Design Output Specification Template
Design Review Checklist
Design Verification Protocol Template
Design Validation Protocol Template
Design History File (DHF) Index
Design Transfer Checklist

Benefits

Address #1 FDA 483 observation category
Traceability from inputs to outputs to V&V
DHF structure that impresses auditors
Avoid costly design-related recalls

Is This For You?

This toolkit is designed for teams facing these challenges:

Design controls are informal or missing
FDA 483 cited design control deficiencies
DHF is disorganized or incomplete
No traceability between requirements and testing

Who This Is For

R&D teams at medical device companiesQA managers implementing design controlsStartups formalizing development processes

Frequently Asked Questions

Is this QMSR-aligned?

Yes, templates reference both current Part 820 and QMSR requirements.

Does this include software design controls?

Basic software considerations included. For full IEC 62304, see SaMD Toolkit.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

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