Chicago Chapter: Medical Device Software Risk Management and Cybersecurity Risks

When:  Sep 19, 2019 from 5:30 PM to 8:30 PM (ET)

RAPS Members: $30
Nonmembers:  $45

Is your medical device software risk management prepared to address cybersecurity risks? Is your documentation updated to the latest standards? New FDA guidance introduced requirements for medical device manufacturers with software and it may effect you. The RAPS Chicago Chapter invites you to join in on learning strategies that can help your company navigate the higher level of scrutiny, including: 

  • Overview of ISO 14971:2007 and EN ISO 14971:2012
  • Advantages of early integration of risk management in product development
  • Beyond Safety – Considerations for Security Risk
  • FDA Guidance on Cybersecurity
  • AAMI ANSI TIR57 Principles for medical device security – risk management
  • Overview of US and International Standards for Cybersecurity
  • Anticipated Changes to ISO 14971

This program, hosted by AbbVie Inc, is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits.



26525 N Riverwoods Blvd
Mettawa, IL 60045-3440