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Radiotherapy AI
Radiotherapy AI’s QMS and TechDoc
Intended Use
Autocontouring
Surface guided radiotherapy
Classifications and Regulatory Checklists
MDR Classification Document
Checklist: MDR General Safety and Performance Requirements
EC Declaration of Conformity
Essential Requirements MDD (93/42/EEC)
User Manual [enter Product Name]
Quality Management System
Quality Manual, Policy and Objectives
ISO 13485:2016 Mapping of Requirements to Documents
Feedback Management and Customer Complaints
Internal Audit
Product Certification and Registration
Update of Regulations
Corrective and Preventive Action
List of CAPAs
Document and Record Control
Document List QMS
Human Resources Administration
List of Medical Device Consultants
List of Training Documentation
Training Record
Management Review
Management Review Report
Post-Market Surveillance
Periodic Safety Update Report
Post-Market Clinical Follow-Up Plan (PMCFP)
Post-Market Clinical Follow-Up Report (PMCFR)
Post-Market Surveillance Plan
Purchasing
List of Qualified Suppliers
Supplier Checklist
Software Validation
Software List
<Software Title> - Software Validation Form
Vigilance
Field Safety Notice Template
Incident Assessment Form
Technical Documentation File
Document Roadmap TechDoc
List of Known Anomalies
14971
Failure Mode and Effects Analysis (FMEA): Risk Acceptance Matrix
Risk Management Plan
Risk Management Report
Failure Mode and Effects Analysis (FMEA): Risk Table
62304
IEC 62304:2006 Mapping of Requirements to Documents
AI Algorithm Validation Report
Bug Fixes Documentation List
Change Evaluation List
Checklist: Software Release
Checklist: Software Requirements Review
Checklist User Needs Review
List of Medical Devices
Software Architecture Checklist
Software Architecture Description
Software Development and Maintenance Plan
Software Requirements List
Software System Test Plan
Change Management
Deployment
Integrated Software Development
SOP Software Problem Resolution
SOUP List (Software of Unknown Provenance)
User Needs List
62366
IEC 62366-1:2015 Mapping of Requirements to Documents
List of Hazard-Related Use Scenarios
Usability Evaluation Plan
Usability Evaluation Protocol
Usability Evaluation Report
Clinical Evaluation
Clinical Evaluation Plan
Clinical Evaluation Report
Data Protection
Website Data Protection Statement
Data Protection and Confidentiality Agreement
List of Data Processing Activities
<Product Name> - Technical and Organizational Measures
repository
open issue
.md
.pdf
62304
62304
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