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:20260831T094540Z - 52171@odoo-57766ccd69-mgjlj DTSTART;TZID=Europe/Stockholm:20261013T140000 DTEND;TZID=Europe/Stockholm:20261013T170000 CREATED:20260831T094540Z DESCRIPTION:IEC 81001-5-1 Cyber security for medical devices training course\nLearn the requirements o f IEC 81001-5-1 Health software and health IT systems safety\, effectivene ss and security. On September 27\, 2023\, the FDA issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. In it\, the FDA recommends implementati on and adoption of a "Secure Product Development Framework" or "SPDF". IEC 81001-5-1\, a reference standard for health software\, is an ideal framew ork to consider. The MDR requires that software shall be developed and man ufactured in accordance with the state of the art taking into account the principles of development life cycle\, risk management\, including informa tion security\, verification and validation. Today\, IEC 81001-5-1 is cons idered that state of the art for cybersecurity within the development life cycle. Key TopicsOverview of 81001-5-1Regulatory PathwaysTypes of 81001-5- 1 submissionsPreparing a submission81001-5-1 Review Process 1. Steps and t imelines 2. Interacting with the vendor during the review process 3. Respo nding to Requests for Additional InformationCase Studies and Best Practice s Educational goals After this course\, participants will have a comprehen sive understanding of 81001-5-1 as well as how to categorize health softwa re in preparation for submission a third-party assessor\, enabling them to effectively prepare\, submit\, and navigate regulatory requirements for m edical software SPDF. Target group This course is intended for quality and regulatory professionals working with medical devices\, medical device co mpany management and employees who need to learn more about IEC 81001-5-1 and SPDF. Course language English Please note: Intertek operates under str ict standards of independence\, impartiality\, and integrity. Read more ab out how we work here: https://www.intertek.com/about/co​mpliance-governa nce/ Course Leaders Shiva Mokhberi [...] DTSTAMP:20260831T094540Z SUMMARY:IEC 81001-5-1 Cybersecurity for medical devices training course X-ALT-DESC;FMTTYPE=text/html:IE C 81001-5-1 Cybersecurity for medical devices training course\nLearn t he requirements of IEC 81001-5-1 Health software and health IT systems saf ety\, effectiveness and security. On September 27\, 2023\, the FDA issued a final guidance titled Cybersecurity in Medical Devices: Quality System C onsiderations and Content of Premarket Submissions. In it\, the FDA recomm ends implementation and adoption of a "Secure Product Development Framewor k" or "SPDF". IEC 81001-5-1\, a reference standard for health software\, i s an ideal framework to consider. The MDR requires that software shall be developed and manufactured in accordance with the state of the 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 cybersecurity within the development lifecycle. Key TopicsOverview of 81001-5-1Regulatory Pathways Types of 81001-5-1 submissionsPreparing a submission81001-5-1 Review Proce ss 1. Steps and timelines 2. Interacting with the vendor during the review process 3. Responding to Requests for Additional InformationCase Studies and Best Practices Educational goals After this course\, participants will have a comprehensive understanding of 81001-5-1 as well as how to categor ize health software in preparation for submission a third-party assessor\, enabling them to effectively prepare\, submit\, and navigate regulatory r equirements for medical software SPDF. Target group This course is intende d for quality and regulatory professionals working with medical devices\, medical device company management and employees who need to learn more abo ut IEC 81001-5-1 and SPDF. Course language English Please note: Intertek o perates under strict standards of independence\, impartiality\, and integr ity. Read more about how we work here: https://www.intertek.com/about/co ​mpliance-governance/ Course Leaders Shiva Mokhberi [...] END:VEVENT END:VCALENDAR