PTD - Test updated documentation templates and data files

[AnilMistry]

Create the list of the order of documents to fill in. this should follow the Design and development SOP to start with, with other QMS SOP following.

Order to fill out Templates

1. Literature Review Template
2. Quality Improvement and Patient Safety Submission Template
3. Training Data Template
4. Medical Device Regulations Classification Template
5. Design Plan Template Template
6. System Requirements Specification Template
7. Clinical Risk Management Template
8. Hazard log Template
9. System Design Specification Template
10. System Architecture Diagram Template
11. Software Description Template
12. Verification and Validation Plan Template
13. Verification and Validation Result Template
14. Clinical Safety Case Report Template
15. Instructions for Use Template
16. Cyber Security Template
17. Acceptance Criteria Template
18. Release Documentation Template
19. Documentation-Level Evaluation Template
20. Unresolved Anomalies Template
21. Post Market Surveillance Plan Template

[MTedder1]

General suggestions:

• Make it generalisable (in readme?) to non ML applications?

Suggestion for 4. Medical Device Regulations Classification Template:

• Pre-populate the roles and responsibilities table if they're generic?

design-plan issues:

• {device.mhra_classification} tag used but in device.yml the tag is {device.mhra_class}

risk.yml issues:

• 'hazard_id' is used in the 'hazard-log.md' doc, but 'id' is used in risk.yml

device.yml issues:

• 'BS62304_class' is used in medical-device-regulations-classification.md but in device.yml it is 'safety_class'. but safety_class is used in system-design-specification.md

requirements.yml issues:

• in system-design-specification.md 'sys_des_spec' is expected but 'specification' is used in requirements.yml.