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:20261028T213104Z - 93772@odoo-54dc9f858c-c7xvh DTSTART;TZID=Europe/Stockholm:20261013T140000 DTEND;TZID=Europe/Stockholm:20261013T170000 CREATED:20261028T213104Z DESCRIPTION:IEC 81001-5-1 Cybersecurity for medical devices training course\nLea rn the requirements of IEC 81001-5-1 Health software and health IT systems safety\, effectiveness and security. On September 27\, 2023\, the FDA iss ued a final guidance titled Cybersecurity in Medical Devices: Quality Syst em Considerations and Content of Premarket Submissions. In it\, the FDA re commends implementation and adoption of a "Secure Product Development Fram ework" or "SPDF". IEC 81001-5-1\, a reference standard for health software \, is an ideal framework to consider. The MDR requires that software shall be developed and manufactured in accordance with the state of the art tak ing into account the principles of development life cycle\, risk managemen t\, including information security\, verification and validation. Today\, IEC 81001-5-1 is considered that state of the art for cybersecurity within the development lifecycle. Key TopicsOverview of 81001-5-1Regulatory Path waysTypes of 81001-5-1 submissionsPreparing a submission81001-5-1 Review P rocess 1. Steps and timelines 2. Interacting with the vendor during the re view process 3. Responding to Requests for Additional InformationCase Stud ies and Best Practices Educational goals After this course\, participants will have a comprehensive understanding of 81001-5-1 as well as how to cat egorize health software in preparation for submission a third-party assess or\, enabling them to effectively prepare\, submit\, and navigate regulato ry requirements for medical software SPDF. Target group This course is int ended for quality and regulatory professionals working with medical device s\, medical device company management and employees who need to learn more about IEC 81001-5-1 and SPDF. Course language English Please note: Intert ek operates under strict standards of independence\, impartiality\, and in tegrity. Read more about how we work here: https://www.intertek.com/about/ co​mpliance-governance/ Course Leaders Shiva Mokhberi [...] DTSTAMP:20261028T213104Z 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 trainin g course\nLearn the requirements of IEC 81001-5-1 Health software and health IT systems safety\, effectiveness and security. On September 27\, 2 023\, the FDA issued a final guidance titled Cybersecurity in Medical Devi ces: Quality System Considerations and Content of Premarket Submissions. I n it\, the FDA recommends implementation and adoption of a "Secure Product Development Framework" or "SPDF". IEC 81001-5-1\, a reference standard fo r health software\, is an ideal framework to consider. The MDR requires th at software shall be developed and manufactured in accordance with the sta te of the art taking into account the principles of development life cycle \, risk management\, including information security\, verification and val idation. Today\, IEC 81001-5-1 is considered that state of the art for cyb ersecurity within the development lifecycle. Key TopicsOverview of 81001-5 -1Regulatory PathwaysTypes of 81001-5-1 submissionsPreparing a submission8 1001-5-1 Review Process 1. Steps and timelines 2. Interacting with the ven dor during the review process 3. Responding to Requests for Additional Inf ormationCase Studies and Best Practices Educational goals After this cours e\, participants will have a comprehensive understanding of 81001-5-1 as w ell as how to categorize health software in preparation for submission a t hird-party assessor\, enabling them to effectively prepare\, submit\, and navigate regulatory requirements for medical software SPDF. Target group T his course is intended for quality and regulatory professionals working wi th medical devices\, medical device company management and employees who n eed to learn more about IEC 81001-5-1 and SPDF. Course language English Pl ease note: Intertek operates under strict standards of independence\, impa rtiality\, and integrity. Read more about how we work here: https://www.in tertek.com/about/co​mpliance-governance/ Course Leaders Shiva Mokhberi [ ...] END:VEVENT END:VCALENDAR