BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:62706 DTSTAMP:20260602T162016Z SUMMARY:Information on Cyber Security to Include in Medical Device Sub missions DESCRIPTION:This training will focus on the new draft guidance documen t recently released by the FDA on ensuring medical device cybersecurit y. Attendees will gain insight into the security activities and docume ntation that are required to prepare for FDA submissions.\n\nWhy Shoul d You Attend:\nAddressing the cybersecurity of medical device software can no longer be an afterthought. Manufacturers developing medical de vices need to identify security risks, mitigate vulnerabilities, emplo y patching and update processes, and develop appropriate incident resp onse plans for their medical device products.\nThe webinar will help d esigners, 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 prom ote “security by design” concepts and provide ideas for best-pract ice security implementations. It will help the attendees understand me dical device cybersecurity risks, design of security controls and miti gations and cybersecurity related documentation that the FDA will like ly review.\nAreas Covered in the Webinar:\n\nExamples of know cybersec urity vulnerabilities that put patients at risk\nThe FDA draft guidanc e addressing cybersecurity of medical devices, Content of Premarket Su bmission for Management of Cybersecurity in Medical Devices, and relat ed industry standards\nResponsibilities of Device Manufacturers to ens ure Confidentiality, Integrity, and Accessibility Control and examples of what needs to be included in software development and a submission regarding each of these. These concepts fulfill the NIST notion of Secure by Design.”\nCybersecurity activities and deliverables that become part of the medical device technical file and FDA submission\nQ uestions and answers\n\nWho Will Benefit:\n\nSoftware engineers who ne ed to understand what the regulatory requirements are for the developm ent of secure medical device software.\nRegulatory affairs professiona ls who need to understand the cybersecurity related documentation that should be included in technical files and FDA submissions.\nSecurity professions who are responsible for defining and documenting security functional requirements and providing input to software quality assura nce for testing.\nSoftware quality assurance that needs to design test s to demonstrate and generate evidence that the cybersecurity requirem ents are met.\n\nInstructor Profile:\nKen Stineman, is the Founder an d CTO of Double Helix LLC, located in San Jose, California. Double-Hel ix provides technical and security advisory services and resources for life-science and personalized medicine companies. Mr. Stineman has fo cused on providing guidance in health information security and privacy , HIPAA and HITECH compliance, vulnerability assessment, gap analysis, and defense-in-depth to ensure the confidentiality and integrity of p atient information.\n\nFor more information visit https://medtechiq.ni ng.com/events/information-on-cyber-security-to-include-in-medical-devi ce DTSTART;TZID=America/New_York:20131205T100000 DTEND;TZID=America/New_York:20131205T111500 CATEGORIES:medical, related LOCATION:Online Event WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu s/~product_id=703181?channel=medtechiq URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p roduct_id=703181?channel=medtechiq CONTACT:+1-650-620-3915 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562006613?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR