Software Development for Medical Device Professionals

This one and a half day course will be most valuable to medical device engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers (particularly in product development). This course will also be of benefit to quality assurance and regulatory affairs personnel who are new to the industry or their current position and do not have an in-depth knowledge of Medical Device Software requirements.

The program also provides an opportunity for more experienced personnel, including middle and upper management, to update and broaden their knowledge of the FDA’s software development requirements.

Learning Objectives

Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of software development design control for medical devices. Particular emphasis will be placed on effective design strategy, as all too often unnecessary time and money is spent on ineffective software design control processes.

The first day will cover topics including software development, software design control procedures and will include software development models and regulatory strategy. The second day will discuss the practical aspects of creating and managing the software development program.

Course Description

This continually updated course covers current FDA regulatory compliance with respect to developing medical device software. A focus will be placed on both the regulation and FDA’s supplemental guidelines.

Among the topics to be discussed: Context of software development within the overall quality system and regulation (QSR), software related procedures, forms, records, safety/risk management strategies, documentation strategies, software evolution strategies, and strategies for integrating the general quality system procedures into the software development program.

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COURSE AGENDA

FIRST DAY

Introduction to Software within Medical Devices

• Why is software treated differently within design control?
• Background of FDA regulation (law)
• Software Design Concepts Overview:
- The Marketing Interface
- Agile Software Concepts
- Software Design for the FDA
- Software Design for the US + EU
• Discussion of key FDA Software guidelines and publications (recommendations)
- Design Control Guidance For Medical Device Manufacturers
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
- Off-The-Shelf Software Use in Medical Devices
- An Introduction to Human Factors in Medical Devices
- Glossary of Computerized System and Software Development
- Terminology
• Software development standards: AAMI SW68, ISO 12207, IEC62304
• FDA QSR vs. ISO 9001 quality system aspects, what applies to software?
• 21 CFR Part 11 strategies for embedded devices

Overall Quality System Strategy for Meeting FDA and ISO Expectations

• Discussion of Quality System and overall Design Control procedures that are used for software
• Topics for the software development procedure within the design control program
• Use of project standards for the each software development project
• Use of AAMI/ISO/IEC standards, certification using 3rd party tools and services
• Problems with using software standards

Models for Developing Software

• Recommendations for documenting software –
- Plans
- Specifications/requirements
- Design descriptions
- Coding comments
- Test protocols
- Traceability documents
- Types of Analyses
• Off the shelf (OTS) software
- Special considerations
- Discussion of FDA guidance
• Cases involving design reuse – advantages, disadvantages, strategies for documentation
• Models for newly developed software
• Managing the software development environment and tools
• Special cases
- Multi-site considerations
- Single developer situations
• Configuration Management and Versioning control
• Design loops
• Test Driven Development
• Planning and managing iterations

SECOND DAY

Software Safety and Risk Management

• Importance of effective overall design philosophy for performance and safety
• Importance of software architecture
• Hardware considerations; redundant processors, fail-safe systems, watchdog timers
• Use of international standards
• Applying risk management techniques to software

Software Validation and Verification (V&V)

• Definitions
• Specific FDA guidance
• Tools and techniques for detecting bugs
• Recommendations for informal and formal software evaluation
• Strategies considerations for software validation
• Strategies considerations for software verification
• Requirements for managing prototypes, including units scheduled for field

Post Release Considerations

• Planning for post release changes
• Tools and techniques for detecting anomalies (bugs)
• Version control and management in a field setting
• Old vs. new versions
• Managing multiple configurations within each version
• Practical recommendations

This course ends at 1:00pm on the 2nd day.