RAPS Members: $30
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.
Featured speaker: Michael Lynch, managing consultant, Intertek
Local contact: Joseph Orlowski, RAC, RAPS Chicago Chapter
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at email@example.com.