Medical Device Software Risk Management, Cybersecurity and Assurance Case: One and a Half Day In-Person Seminar

Course Description:

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.

Learning Objectives:

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