Ultimate AI Risk Management for Medical Devices (2024 Pro)
Focused View
1:04:31
1 - Introduction.mp4
01:35
2 - BSAAMI 349712023 Application of ISO 14971 to machine learning in artificial intelligence Guide.txt
2 - EVSEN ISO 149712019A112021 Medical devices Application of risk management to medical devices ISO 149712019.txt
2 - ISOTR 249712020 Medical devices Guidance on the application of ISO 14971.txt
2 - What is ISO14971.mp4
07:36
3 - Key Definitions and Concepts in ISO 14971.mp4
06:18
4 - Competence of personnel.mp4
04:48
4 - Competence-Checklist-for-Risk-Management.docx
5 - AI-Whitepaper-BuildingExplainability-final3.pdf
5 - FDA 21 CFR PART 820QUALITY SYSTEM REGULATION.txt
5 - FDA eSTAR Template.txt
5 - Premarket-Software-Functions-Guidance.pdf
5 - Regulation EU 2017745 of the European Parliament.txt
5 - Regulatory requirements.mp4
05:58
5 - bsi-md-mdr-best-practice-documentation-submissions-en-gb.pdf
5 - md-mdcg-2019-11-guidance-qualification-classification-software-en-0.pdf
5 - md-mdcg-2021-mdsw-en.pdf
6 - Risk Management Process.mp4
02:09
7 - Risk Management Plan.mp4
03:45
7 - risk-management-plan-template-2013.doc
7 - security-risk-management-plan-template-2024.doc
8 - Hazard-Identification-and-Hazardous-Situations-Table.pdf
8 - Risk Analysis.mp4
11:47
8 - Risk-Management-Table-with-Hazard-Prob-Severity.pdf
8 - risk-analysis-template-2013.doc
9 - Risk Evaluation.mp4
03:02
10 - Risk control.mp4
04:26
10 - Risk-Management-Table-with-Verification-Validation-and-Mitigations.pdf
11 - Evaluation of overall residual risk.mp4
06:20
11 - Risk-Benefit-Analysis-Template.pdf
11 - Risk-Management-Report.pdf
11 - Risk-Management-Table.pdf
11 - security-risk-assessment-report-template-2023.doc
12 - Risk management review.mp4
03:23
12 - Risk-Management-Review-Template.pdf
13 - AI-Software-Release-Document-Template-with-Examples.pdf
13 - PMS-Plan-Template.pdf
13 - PMS-Report-Template.pdf
13 - Production and postproduction activities.mp4
03:24
13 - version-description-template.doc
More details
Course Overview
Master ISO 14971 risk management standards for AI-powered medical devices with this comprehensive guide covering regulatory requirements, hazard analysis, and post-production monitoring.
What You'll Learn
- Key ISO 14971 concepts and regulatory frameworks (FDA/EU)
- How to conduct risk analysis and evaluation for AI medical devices
- Best practices for documentation and compliance reporting
Who This Is For
- Medical device quality engineers
- AI software developers in healthcare
- Regulatory affairs professionals
Key Benefits
- Practical templates for risk management plans and reports
- Latest 2023-2024 regulatory guidance documents
- Checklists for personnel competence assessment
Curriculum Highlights
- ISO 14971 Fundamentals & AI Applications
- Regulatory Requirements (FDA/EU MDR)
- Risk Management Process Implementation
Focused display
Category
- language english
- Training sessions 13
- duration 1:04:31
- Release Date 2025/05/27
