Managing software risk in medical devices is critical and challenging. While the risk management standard ISO 14971 provides a process framework and is FDA recognized for medical device risk management, its practical implementation for software applications can be difficult and confusing. The FDA has issued number of guidance documents related to software risk management over recent years, such as those on mobile medical applications, cybersecurity devices, and infusion pump total product life cycle.
This seminar on medical device software risk management aims to address the following questions:
- How can a medical device manufacturer or healthcare information system provider overcome these technical as well as regulatory compliance challenges?
- What are the resources and tools available?
- What are the industry’s best practices?
- What are FDA’s latest updates on medical device software best practices?
During this two day course, the instructor will also introduce the standards and guidance relevant to medical device software, discuss the FDA’s updates on software risk management, and provide industry best practices including techniques and tools to achieve compliance and effectively assure medical device software safety.
Guest Speaker Paul Jones works at FDA in the Center for Devices and Radiological Health, Office of Science and Engineering Laboratories (OSEL). He serves as an in-house consultant on regulatory matters involving medical device software system safety, software engineering, risk management, and safety assurance cases
Upon completing this course on managing software risk in medical device, participants will be able to:
- Use FDA’s latest research on medical device software best practices
- Get an overview of software risk management related standards and guidance including:
- ISO 14971:2007 and EN ISO 14971:2012, IEC 62304 Medical Device Life Cycle Process, IEC TR 80002-1 Application of ISO 14971 for Software
- FDA Guidance on Mobile Medical Applications, Cybersecurity in Medical Devices, Infusion Pump Total Product Life Cycle
- Learn techniques and best practices on how to:
- identify software related risks
- identify software risk control and mitigation measures
- assess and evaluate risk contributed/caused by software (pre-market and post-market field issues)
- assure the completeness and adequacy of risk management
- communicate risk management information throughout the life of the product
- Understand key success factors for effective software risk management
Who will Benefit:
This course will be beneficial for the personnel in medical device companies. The following job titles/ positions will benefit from attending this seminar:
- Software/System Engineers/Managers/Directors
- QA/RA members/Managers/Directors
- Risk Management Engineers/Managers/Directors
- Hospital Biomedical Engineers
- Hospital Risk Managers
- Regulators of government or notified bodies
- Compliance Officers
Software has increasingly become a critical part of our healthcare system. More and more medical devices have software embedded or interface with another device or healthcare system that has software as an integral part. Fast advancement and broad availability of digital technology, internet, wireless, mobile devices and apps have enabled us to utilize software to process medical and healthcare information that ranges from basic information sharing, connectivity, device/system interoperability and control to health disease diagnostics, clinical decision making, or smart device-driven patient treatments. While we strongly demand and greatly benefit from these medical applications, the complexity of the applications and the healthcare system as a whole is continuously increasing and has introduced new vulnerabilities such as cybersecurity. As a brain to our body, software is the brain of these applications and the healthcare system. The “brain” needs to consider, control and mitigate risks associated. Given the increased complexity of the applications and healthcare system as a whole, medical device software risk management is critical and challenging.