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  • Information on Cyber Security to Include in Medical Device

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Dec 05, 2013 10:00 AM
  • End Time:
  • Thursday - Dec 05, 2013 11:15 AM
  • Location:
  • Online
  • This training will focus on the new draft guidance document recently released by the FDA on ensuring medical device cybersecurity. Attendees will gain insight into the security activities and documentation that are required to prepare for FDA submissions.

    Why Should You Attend:
    Addressing the cybersecurity of medical device software can no longer be an afterthought. Manufacturers developing medical devices need to identify security risks, mitigate vulnerabilities, employ patching and update processes, and develop appropriate incident response plans for their medical device products.
    The webinar will help designers, software developers, and quality engineers better understand the changing security regulations and increase awareness of the types of vulnerabilities that impact medical devices. The session will promote “security by design” concepts and provide ideas for best-practice security implementations. It will help the attendees understand medical device cybersecurity risks, design of security controls and mitigations and cybersecurity related documentation that the FDA will likely review.

    Who Will Benefit:
    -Software engineers who need to understand what the regulatory requirements are for the development of secure medical device software.
    -Regulatory affairs professionals who need to understand the cybersecurity related documentation that should be included in technical files and FDA submissions.
    -Security professions who are responsible for defining and documenting security functional requirements and providing input to software quality assurance for testing.
    -Software quality assurance that needs to design tests to demonstrate and generate evidence that the cybersecurity requirements are met.
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