This roadmap outlines the process for creating the TechDoc file, organized by “Design Phase”. Each document has an assigned author who is responsible for its creation. Proceed through each phase step-by-step, although documents within a phase can be completed in a different order. It is recommended to finalize all documents within a phase before moving to the next.
PHASE 1: Planning & Feasibility
| Document | Author | Comment |
|---|---|---|
| Intended Use | CEO | This is a crucial document for your TechDoc, as it forms the basis for both business and regulatory strategies. |
| Medical Device Classification | QA/RA Manager | Establishes the product’s medical device classification per MDR guidelines. |
| Product Roadmap | Product Manager | While not essential, this document aids in feasibility analysis and resource allocation, helping to track upcoming development phases. |
| Software Development and Maintenance Plan | Software Developer | Provides product-specific details on development tools, resources, and methodologies. Assists development teams in aligning on the setup and strategy. |
| Change Evaluation List | QA/RA Manager | Details and evaluates discrepancies between the current and next software version, based on MDCG 2020-3. Not necessary for the initial release. |
| Risk Management Plan and Risk Acceptance Matrix | Risk Manager | Outlines the methods used to assess risks for the product, defining probability and severity levels and setting acceptable limits. |
| Clinical Evaluation Plan | Clinician / Scientific Person | Details the approach for evaluating clinical benefits and risks of the product. |
PHASE 2: Specification
| Document | Author | Comment |
|---|---|---|
| User Needs List | Product Manager | A high-level overview of user requirements, most of which will be detailed in the Software Requirements. |
| User Needs Checklist | QA/RA Manager | Verifies the logic and completeness of the User Needs List. |
| Software Requirements List | Developer-adjacent person | Describes how user needs will be incorporated into the software, detailing specific features and requirements. |
| List of Hazard-Related Use Scenarios | Risk Manager | Identifies scenarios in which users might be exposed to potential hazards. |
| Risk Table | Risk Manager | Outlines and evaluates potential risks, consolidating input from various sources. |
| Software Requirements Checklist | QA/RA Manager | Ensures the Software Requirements List is logically structured and complete. |
| Software Test Plan | Software Developer | Maps out the tests for each Software Requirement to ensure coverage and validation. |
| Usability Test Plan | Product Manager / Usability Engineer | Outlines the methodologies for conducting usability tests. |
PHASE 3: Development
| Document | Author | Comment |
|---|---|---|
| SOUP List | Software Developer | Comprehensive list of external libraries, frameworks, and packages used in the product, including their criticality assessments. |
| Software Architecture | Software Developer | Provides a visual representation and description of the software components and their interactions. |
This phase involves actual coding work. The SOUP list and software architecture should be prepared before development starts and adjusted as needed throughout the coding process. Though these documents ideally should be pre-made, the iterative nature of development often necessitates their creation alongside programming.
PHASE 4: Verification and Validation
| Document | Author | Comment |
|---|---|---|
| Software Test Results | QA Tester | Records the outcomes of the software testing process, including pass/fail status. |
| List of Known Anomalies | Software Developer / Product Manager | Details known bugs and failed tests, with justifications for their acceptance, explaining how the product’s benefit and safety remain intact and noting plans for future fixes. |
| Instructions For Use | Person with the best overview | Provides comprehensive usage instructions for the product. |
| Usability Test Protocol | Product Manager / Usability Engineer | Outlines test cases for assessing User Needs, Hazard-Related Use Scenarios, and Instructions for Use. |
| Usability Test Report | Product Manager | Summarizes findings and results from the usability testing phase. |
| Clinical Evaluation Report | Clinician / Scientific Person | Analyzes data to verify the product’s safety and efficacy. |
| Risk Management Report | Risk Manager | Summarizes risk management activities and findings. |
PHASE 5: Product Release
| Document | Author | Comment |
|---|---|---|
| GSPR List | QA/RA Manager | Verifies compliance with the “General Safety and Performance Requirements” as outlined in applicable regulations. |
| PMS (/PMCF) Plan | QA/RA Manager | Details post-market surveillance plans, including Post-Market Clinical Follow-Up if initial clinical data is insufficient. |
| Software Release Checklist | QA/RA Manager | Confirms that all requirements are met, documentation is complete, and the product is ready for safe use. |
| Release Notes | Product Manager OR Software Developer | Outlines new features and changes in the release. |
| Declaration of Conformity | QA/RA and CEO | Affirms the product’s conformity with relevant regulations and standards. |