Course Description
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, as well as recent FDA Guidance Documents on Cybersecurity, Mobile Apps, and Usability.
Who Should Attend
This course is designed for software engineers, project managers, quality managers, software quality professionals, RA/QA staff. It is also appropriate for people who are new to the medical device industry.
Learning Objectives
Through training, participants will learn 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.
Course Outline
Day 1 Topics (7 hours)
- Regulatory Roadmap
- Regulations – FDA and EU
- FDA QSR, Part 11 and EU MDR and IVDR
- Medical Device Definitions – FDA and EU
- FDA Guidance Documents for Software
- International Standards
- ISO 13485, ISO 14971, IEC 62304, IEC 62366-1
- Related Regulatory Topics
- Types of Software Regulated by FDA
- FDA View of R&D
- QMS Documentation Pyramid
- Cybersecurity Threat Modeling
- Discussion Questions
Interpreting FDA Design Controls and 62304 – Part 1
- Context: ALL Software is Defective
- Design and Development Planning
- Software Development Procedure and Plan
- Software Development Lifecycle Model
- Design Inputs: Software Requirements
- Creating Unambiguous Requirements
- Requirements Traceability
- FDA and IEC 62304 Requirements
- Design Outputs: Software Architecture and Design
- FDA and IEC 62304 Requirements
- Design Changes: What is Required for Software
- Triage and Defect Life Cycle
- Root Cause Analysis and CAPA
- Discussion Questions
Day 2 Topics (7 hours)
Interpreting FDA Design Controls and 62304 – Part 2
- Design Verification Activities for Software
- Verification Planning
- Technical Reviews
- Unit, Integration and System Testing
- Static Analysis
- Requirements, Architecture, Design Verification
- Unit, Integration and System Test Verification
- FDA and IEC 62304 Requirements
- Design Validation Activities for Software
- Design Validation and Software Validation
- Testing Overview and Software Validation Planning
- FDA Requirements
- Design Transfer – Special Requirements for Software
- Design History File
- Discussion Questions
- Validation of…
- Software Tools used to develop Medical Device Software
- Software used in Production and Quality Systems
- Risk Management
- Terms and Concepts
- Risk Management Process
- Software-specific Issues
- Risk Management Tools and Techniques
- Fault Tree Analysis vs. FMEA
- Production and Post-production Activities
- Documentation Repositories
- Discussion Questions
- Summary and Course Wrap-up
Prerequisites
n/a
Course Format
14 hours
Training is presented virtually by a live instructor.
Course notes, access to an extensive collection of reference documents, and a training certificate are provided.
Course instructor: Steven Rakitin – Consultant, Software Engineering
9:00am – 5:00pm (EST)
Follow QSG on LinkedIn!
Become a QSG Member today!