Artificial Intelligence Risk Management For Medical Device

سرفصل های دوره

1 - Introduction

1 - Introduction

2 - What is ISO14971

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

3 - Key Definitions and Concepts in ISO 14971

3 - Key Definitions and Concepts in ISO 14971

4 - Competence of personnel

4 - Competence of personnel

4 - Competence-Checklist-for-Risk-Management.docx

5 - Regulatory requirements

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

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

6 - Risk Management Process

7 - Risk Management Plan

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

8 - Risk-Management-Table-with-Hazard-Prob-Severity.pdf

8 - risk-analysis-template-2013.doc

9 - Risk Evaluation

10 - Risk control

10 - Risk-Management-Table-with-Verification-Validation-and-Mitigations.pdf

11 - Evaluation of overall residual risk

11 - Risk-Benefit-Analysis-Template.pdf

11 - Risk-Management-Report.pdf

11 - Risk-Management-Table.pdf

11 - security-risk-assessment-report-template-2023.doc

7 - Risk management review

12 - Risk management review

12 - Risk-Management-Review-Template.pdf

8 - Production and postproduction activities

13 - AI-Software-Release-Document-Template-with-Examples.pdf

13 - PMS-Plan-Template.pdf

13 - PMS-Report-Template.pdf

13 - Production and postproduction activities

13 - version-description-template.doc

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تولید کننده: Udemy