Quality Training

Software as a Medical Device (SaMD)

This course will help you understand the requirements of IEC 62304 and the importance for medical device manufacturers.

This 22-hour course explores the IEC 62304 standard clause by clause to ensure a thorough understanding of the requirements. During this course, you will be provided with an understanding of how IEC 62304 aligns with Design Control and Risk Management towards meeting the new European MDR and IVDR and the US requirements of FDA 21 CFR 820, QMSR.

Delivered virtually over 4 half-days (11:30 - 17:00) by Meddev Solutions, a Trinzo company.

Content includes

Day 1 - Regulatory Overview

• ISO 13485 Software Requirements
• MDR 2017/745 / IVDR 2017/746 Software Requirements
• MDR (UK) 2002 Software Requirements
• FDA 21 CFR Part 820
• MDCG Guidance / Consensus Guidance
• Software Definitions
• Software Development Life Cycle (SDLC)
• Software Classification
• Security & Data Protection

Day 2 - Practical

• Software Development Planning
• Intended Use & User Needs
• Software Requirements Specification
• Integration with ISO 13485/QMSR Change Control and Design Control
• Integration with ISO 14971 Risk Management
• SBOM & OTS & SOUP
• Tools for Software Risk Analysis
• Integration with IEC 60601 & PEMS
• Integration with IEC 62366
• Software Design

Day 3 - Verification & Validation

• Software V&V Protocols
• Unit Testing
• Integration Testing
• System Acceptance Testing
• Regression Testing
• Problem resolution & residual anomalies
• Software Development Report
• Post Market Surveillance
• Software Maintenance Plan
• Configuration Management
• Traceability
• Residual Risk & Labelling
• Predicate Devices & State of the Art

Day 4 - Cybersecurity

• Security Regulatory Requirements & Guidance
• Security & Data Protection Risk Assessments
• Threat Identification & Modelling
• Penetration Testing
• Security Frameworks
• Vulnerability Management Plan

Learning Outcomes

• Understand the purpose and structure of IEC 62304
• Understand the key terms and definitions used through IEC 62304 (incl. SaMD, Software as a component or accessory, embedded software)
• Describe and understand all elements of IEC 62304 and the deliverables required based on Software Risk Classification
• Understand the interconnection between Software Development, Design Control and Risk Management and Human Factors/Usability Engineering
• Explain with working examples the key deliverables required from IEC 62304
• Understand when IEC 60601 is required Identify Label Requirements for Software including UDI

Who should attend

Software Engineers

Software Managers

Quality Managers

Design Assurance

Managers Software Quality Engineers

Quality Engineers

Regulatory Affairs Professionals

Marketing Internal Auditors

Upcoming dates:

No training dates available at the moment.