BEGIN:VCALENDAR VERSION:2.0 PRODID:-//PYVOBJECT//NONSGML Version 1//EN BEGIN:VTIMEZONE TZID:Europe/Stockholm BEGIN:STANDARD DTSTART:20001029T030000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=10 TZNAME:CET TZOFFSETFROM:+0200 TZOFFSETTO:+0100 END:STANDARD BEGIN:DAYLIGHT DTSTART:20000326T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=3 TZNAME:CEST TZOFFSETFROM:+0100 TZOFFSETTO:+0200 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:20260808T054051Z - 84709@odoo-6c455687b8-9vjd8 DTSTART;TZID=Europe/Stockholm:20261013T140000 DTEND;TZID=Europe/Stockholm:20261013T170000 CREATED:20260808T054051Z DESCRIPTION:IEC 81001-5-1 Cybersecurity for medical devices training course\nL earn the requirements of IEC 81001-5-1 Health software and health IT syste ms safety\, effectiveness and security. On September 27\, 2023\, the FDA i ssued a final guidance titled Cybersecurity in Medical Devices: Quality Sy stem Considerations and Content of Premarket Submissions. In it\, the FDA recommends implementation and adoption of a “Secure Product Development Framework” or “SPDF”. IEC 81001-5-1\, a reference standard for healt h software\, is an ideal framework to consider. The MDR requires that soft ware shall be developed and manufactured in accordance with the state of t he art taking into account the principles of development life cycle\, risk management\, including information security\, verification and validation . Today\, IEC 81001-5-1 is considered that state of the art for cybersecur ity within the development lifecycle. Key TopicsOverview of 81001-5-1Regul atory PathwaysTypes of 81001-5-1 submissionsPreparing a submission81001-5- 1 Review Process 1. Steps and timelines 2. Interacting with the vendor dur ing the review process 3. Responding to Requests for Additional Informatio nCase Studies and Best Practices Educational goals After this course\, par ticipants will have a comprehensive understanding of 81001-5-1 as well as how to categorize health software in preparation for submission a third-pa rty assessor\, enabling them to effectively prepare\, submit\, and navigat e regulatory requirements for medical software SPDF.Target group This cour se is intended for quality and regulatory professionals working with medic al devices\, medical device company management and employees who need to l earn more about IEC 81001-5-1 and SPDF. Course language English Please not e: Intertek operates under strict standards of independence\, impartiality \, and integrity. Read more about how we work here: https://www.intertek.c om/about/co​mpliance-governance/ Course Leaders Shiva Mokhberi Cyber [.. .] DTSTAMP:20260808T054051Z SUMMARY:IEC 81001-5-1 Cybersecurity for medical devices training course X-ALT-DESC;FMTTYPE=text/html:IEC 81001-5-1 Cybersecurity for medical devices train ing course\nLearn the requirements of IEC 81001-5-1 Health software an d health IT systems safety\, effectiveness and security. On September 27\, 2023\, the FDA issued a final guidance titled Cybersecurity in Medical De vices: Quality System Considerations and Content of Premarket Submissions. In it\, the FDA recommends implementation and adoption of a “Secure Pro duct Development Framework” or “SPDF”. IEC 81001-5-1\, a reference s tandard for health software\, is an ideal framework to consider. The MDR r equires that software shall be developed and manufactured in accordance wi th the state of the art taking into account the principles of development life cycle\, risk management\, including information security\, verificati on and validation. Today\, IEC 81001-5-1 is considered that state of the a rt for cybersecurity within the development lifecycle. Key TopicsOverview of 81001-5-1Regulatory PathwaysTypes of 81001-5-1 submissionsPreparing a s ubmission81001-5-1 Review Process 1. Steps and timelines 2. Interacting wi th the vendor during the review process 3. Responding to Requests for Addi tional InformationCase Studies and Best Practices Educational goals After this course\, participants will have a comprehensive understanding of 8100 1-5-1 as well as how to categorize health software in preparation for subm ission a third-party assessor\, enabling them to effectively prepare\, sub mit\, and navigate regulatory requirements for medical software SPDF.Targe t group This course is intended for quality and regulatory professionals w orking with medical devices\, medical device company management and employ ees who need to learn more about IEC 81001-5-1 and SPDF. Course language E nglish Please note: Intertek operates under strict standards of independen ce\, impartiality\, and integrity. Read more about how we work here: https ://www.intertek.com/about/co​mpliance-governance/ Course Leaders Shiva M okhberi Cyber [...] END:VEVENT END:VCALENDAR