ANSI/AAMI SW91:2018 – Classification of Defects in Health Software Training by Tonex
This course provides an in-depth understanding of the ANSI/AAMI SW91:2018 standard, focusing on the classification of defects in health software. Participants will gain practical knowledge of identifying, categorizing, and managing defects to ensure software safety, reliability, and compliance in health applications.
Learning Objectives
By the end of the course, participants will be able to:
- Understand and apply the ANSI/AAMI SW91:2018 defect classification framework.
- Identify and categorize defects in health software.
- Assess defect risks and align practices with regulatory standards.
- Implement defect management processes in real-world projects.
- Drive continuous improvement in health software development through effective defect management.
Audience
This course is designed for:
- Health Software Developers: Professionals involved in the design and development of software for healthcare applications.
- Quality Assurance (QA) Specialists: Individuals responsible for testing and ensuring the quality of health software.
- Regulatory Compliance Professionals: Experts managing compliance with FDA, ISO, and other standards in health software.
- Risk Managers in Healthcare IT: Those assessing and mitigating risks associated with software defects.
- Software Safety Engineers: Engineers focusing on safety-critical software in medical devices and healthcare systems.
- Project Managers: Leaders overseeing the development and maintenance of health software projects.
- Healthcare IT Professionals: Stakeholders involved in the implementation and maintenance of health software systems.
Pre-requisites:
Familiarity with software development and basic understanding of health IT regulations is recommended.
Course Modules:
Day 1: Foundations and Frameworks
Module 1: Introduction to Health Software Defect Classification
- Overview of ANSI/AAMI SW91:2018
- Importance of defect classification in health software safety and performance
- Key terminologies and concepts
Module 2: Types of Defects
- Categories of software defects (e.g., functional, interface, performance)
- Examples of defects in health software systems
- Consequences of unaddressed defects
Module 3: Defect Risk Assessment
- Risk analysis in health software development
- Tools for assessing severity, frequency, and detectability of defects
- Exercise: Classifying and ranking defect risks
Module 4: Compliance and Regulatory Context
- How ANSI/AAMI SW91:2018 aligns with FDA and ISO standards
- Regulatory implications of defect classification
- Best practices for documentation and audits
Day 1 Workshop:
- Case Study Analysis: Examine real-world health software failures. Identify and classify defects using the SW91 framework.
Day 2: Applications and Implementation
Module 5: Defect Management Lifecycle
- Processes for defect detection, documentation, and resolution
- Integrating defect classification into software development lifecycles
- Tools and platforms for defect tracking
Module 6: Implementing ANSI/AAMI SW91:2018 in Practice
- Developing organizational guidelines for defect classification
- Training teams on using the SW91 standard
- Challenges and solutions in implementation
Module 7: Continuous Improvement in Defect Management
- Leveraging defect data for software quality improvement
- Metrics and KPIs for defect management
- Role of AI and automation in health software defect classification
Module 8: Workshop and Certification
- Participants will apply their knowledge in a simulated health software defect scenario.
- Review and feedback on workshop outcomes.
- Certificate of Completion for ANSI/AAMI SW91:2018 Course
Day 2 Workshop:
- Simulation Exercise: Conduct a defect review meeting for a hypothetical health software project. Use the ANSI/AAMI SW91:2018 standard to classify and prioritize defects.