This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes.

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Gartner Security & Risk Management Summit 2021 covers cybersecurity, IT risk management strategy, plans, insights, and more. 

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This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

In the past year, healthcare organizations accelerated digitally to provide virtual care at speed. While beneficial for patients, it introduced data security risks and challenged organizations to maintain an integrated view of the patient across disintegrated systems.

Target audience:

   Medical risk professionals, Board members, Operations managers, Compliance managers

Learning objectives: 

•  Understand and articulate how risk appetite can be applied in a medical setting
• Understand how risk management can assist in improving patient care
•  Leveraging regulatory requirements to add value to the organization
•  Explain how Enterprise Risk Management can be utilized to look beyond clinical risk

As part of your HCCA membership, you will receive four free member-exclusive web conferences a year, valued at $99.00 each!  If you are unable to attend this live web conference, the recording will be available for download after the event. Pre-Registration required. 

Learning Objectives:

• Understand the relationships between Enterprise Risk Management (ERM), Internal Controls, and Compliance & Ethics Programs
• Learn practical applications of ERM to Compliance Risk Management
• Map key characteristics of compliance & ethics programs to the ERM framework