This course will be presented with a live instructor using web-meeting software. The course content will be covered in 4 sessions (1-4pm EST) presented over four days.
Developing software in compliance with the FDA Design Control regulation, changing FDA guidance documents and latest international standards is challenging. This intensive course provides practical solutions and suggestions for developing software in a manner that meets applicable FDA regulations, guidance documents and international standards, such as IEC-62304:2015. The focus is on interpreting Design Controls for software. Each section of the Design Controls regulation (820.30) is discussed from the perspective of software development. Discussions on key topics such as Software Requirements, Traceability, Design Reviews, Software Verification & Validation and Risk Management (including recently updated standards ISO- 14971:2019 and EN-14971:2019) are included. Also discussed are FDA requirements for validation of software development tools and software used in Manufacturing and Quality Systems. Also discussed are recent FDA Guidance Documents on Cybersecurity, Mobile Apps, and Usability.
THIS COURSE IS INTENDED FOR…
Software engineers, project managers, quality managers, software quality professionals, RA/QA staff, and anyone who needs to develop cost-effective processes and procedures that will enable their organizations to deliver high quality software-based medical devices that comply with FDA regulations and international standards. This course is also appropriate for people who are new to the medical device industry. Course notes, access to an extensive collection of reference documents and a training certificate are provided.
This course will be presented with a live instructor using web-meeting software. The course content will be covered in 4 sessions as described below.
SESSION 1 – Regulatory Context
Duration ~3 hours with one 15 min break
This session will cover key regulatory requirements for medical device software in the US and EU.
Regulations and Guidance:
- FDA Medical Device Regulation (21 CFR Part 820 – specifically, design controls)
- EU Medical Device Regulation
- FDA Guidance Documents:
- Guidance for Content of Pre-market Submissions for Medical Devices Containing Software
- Off-the-Shelf Software Use in Medical Devices
- General Principles of Software Validation
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Policy for Software Device Functions and Mobile Medical Applications
- Applying Human Factors and Usability Engineering to Medical Devices
- International Standards:
- ISO 13485:2016 Medical Devices – Quality Management Systems
- IEC 62304: 2015 Medical Device Software – Software Lifecycle Processes
- ISO 14971: 2019 Application of Risk Management to Medical Devices
- EN 14971: 2019 Application of Risk Management to Medical Devices
- Off-the-Shelf (OTS) Software and Open Source software (SOUP)
- Discussion: All Software Is Defective…
SESSION 2 – FDA Design Controls and IEC 62304 – Part 1 Duration ~2.5 hours with one 15 min break
This session will cover FDA Design Controls and IEC 62304 requirements for medical device software.
- Design and Development Planning
- How does Agile Development fit?
- Medical Device Software Lifecycle Processes
- Risk Management
- FDA Levels of Concern
- IEC 62304 Software Safety Classification
- Software Requirements
- Techniques for Removing Ambiguity from Requirements
- Software Architecture and Design
- Software Design Changes
SESSION 3 – FDA Design Controls and IEC 62304 – Part 2 Duration ~2.5 hours with one 15 min break
This session will cover Software Verification and Validation requirements.
- Software Implementation
- Software Verification
- Technical Reviews
- Static Analysis
- Unit and Integration Testing
- System Testing
- Software Validation Testing
SESSION 4 – Software Tool Validation and Risk Management Duration ~2.5 hours with one 15 min break
This session will cover Software Tool Validation and Risk Management requirements.
- Software Tool Validation
- Deciding which tools need to be validated
- Validation approach for software tools
- Validation of Manufacturing Software and Quality System Software
- Risk Management Using Fault Tree Analysis (FTA)
- Review of ISO/EN 14971:2019 Requirements
- Example of Fault Tree Analysis and Failure Modes Effect Criticality Analysis (FMECA)
Course instructor: Steven Rakitin – Consultant, Software Engineering
1:00-4:00pm (EST) each day