Special download page for job aids, checklists, and other tools.
| Aid | Link |
|---|---|
| Checklist: Qualifying for Real-Time PMA Supplement | Checklist to Qualify for a Real-Time PMA Supplement |
| Sample 62304 Amendment 1 Checklist for audits and review of software development process | 62304SoftwareCPR-Checklist_Am1-Sample-20190415 |
| Checklist: 62304 Conformance | 62304 Conformance Checklist Tool |
| Training Aid: 62304 & 82304 Comparison | 62304-82304 requirements comparison |
| Example: Software Development Environment | SW Development Environment Worksheet |
| Checklist: IEC 82304-1 | 82304 Health Software Checklist |
| Training Aid: 62304 & FDA Comparison | 62304 comparison with FDA by safety class |
| Checklist: Releasing/Updating Software | Go-Live Checklist Training Example |
| Example: Software Documentation | Software Documentation Training Example |
| Checklist: Requirements Quality | Requirements Quality Checklist |
| Checklist: EN 62366 | EN 62366 Checklist |
| Template: SoftwareCPR training on production and quality system software validation | QS Validation Form Training Example |
| Templates: SoftwareCPR training on medical device software standards focused on IEC 62304 | SoftwareCPR 62304 Training Template Manual |
| Presentation: Introduction to pre-market submissions for devices that are, or contain, software | Premarket Submission Presentation |
| Presentation: Agile Methods | Agile Methods Compliance Presentation |
| Example & Explanation: Software Development SOP, Software Development Plan, Software Risk Analysis | Compliance Training Templates |
| Example: Software Risk Analysis procedure and report | Software Risk Analysis Training Template |
| Example: 820.70(i)/Validation of Production and Quality System Software | Partial 820.70(i) Training Manual |
| Example: User Interface Design Specification | User Interface Design Spec Training Template |
| Example: Software Requirements Specification | Software Requirements Spec Training Template |
| Example: Device Risk Management SOP | Risk Management Training Example |
| Reference Manual for Validation of Clinical Trials Computer Systems | Clinical Trials Validation Manual |
| Reference Manual for Medical Device SW | Medical Device SW Reference Manual |
| Part 11 Changes Aids | Part 11 Changes and Guidance Training Aid |
| Part 11 Aids | A Roadmap and Training Aid for Part 11 |
| Example: IT Network Handbook | IT Network Handbook Training Example |
| Visual Aid: Key Medical Devices Standards & FDA Guidance | Software Standards and FDA Guidance Visual Aid |
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