BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T000234Z UID:663a9f89-a2cb-4b37-9d1e-525704af3347 DTSTART:20210217T090000 DTEND:20210218T090000 CLASS:PRIVATE DESCRIPTION:
Gaps\, incorrect or incomplete implementation of software ca n delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent\, complete and correct imp lementation of risk management from the start of product development is th erefore imperative. This course will introduce all necessary steps to desi gn\, implement and test critical medical device software in a regulatory c ompliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will addit ionally address the system level risk management and the resulting interfa ces to software.
\n\nTo comprehensively summarize all risk related a ctivities and to demonstrate the safe properties of a device the '\;Saf ety Case'\; or '\;Assurance Case'\; document is a well-establishe d method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (curr ently only required for FDA infusion pump submissions). This course will i ntroduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety rela ted information.
\n\nThe cours e will introduce the main elements of risk management with emphasis on sof tware issues and the application of risk management principles and require ments to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device dev elopment. International consensus\, reflected in globally applicable stand ard requirements\, has led to risk management being a mandatory component of almost any activity in the medical device industry.
\n\nThe cours e will emphasize the implementation of risk management into the developmen t and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and bene ficial undertaking. This seminar will address the system level issues of r isk management as well as the increasingly important software related issu es of critical systems. It will help to comply with regulatory requirement s with minimized overhead and resource burden. To make the combines effort to design\, implement and verify a safe device transparent the concept of an assurance case will be introduced.
\n\nThe course is mainly base d on international consensus requirements such as ISO14971 and IEC62304. p>\n\n
Following personnel will benefit from the course:
\n\nIntroduction i nto Risk Management and Quality System Integration
\n\nRisk Man agement to ISO 14971:2012
\n\n< strong>Software Risk Management (IEC62304 / FDA software reviewers'\; g uidance):
\n\nSafety / Assurance case
\n\nMarkus Weber\,&
nbsp\;Principal Consultant with System Safety\, Inc.\, specializes in safe
ty engineering and risk management for critical medical devices. He gradua
ted from Ruhr University in Bochum\, Germany with a MS in Electrical Engin
eering. Before founding System Safety\, Inc.\, he was a software safety en
gineer for the German approval agency\, TUV. Since 1991\, Mr. Weber has be
en a leading consultant to the medical device industry on safety and regul
atory compliance issues\, specifically for active and software-controlled
devices. In conjunction with the FDA\, he has published works on risk mana
gement issues and software-related risk mitigations. Mr. Weber has helped
multiple companies\, from startups to Fortune 500 firms.
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\nPl
ease contact Marilyn Turner: Phone: +1 929 900 1853  \;Email: marilyn.
turner [a] nyeventslist.com for registrations