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DTSTAMP:20260520T163818Z
SUMMARY:Medical Device Software Risk Management, Cybersecurity and Ass
 urance Case: One and a Half Day In-Person Seminar
DESCRIPTION:Course Description:\nManaging software risk in medical dev
 ices is critical and challenging. While the risk management standard I
 SO 14971 provides a process framework and is FDA recognized for medica
 l device risk management, its practical implementation for software ap
 plications can be difficult and confusing. The FDA has issued number o
 f guidance documents related to software risk management over recent y
 ears, such as those on mobile medical applications, cybersecurity devi
 ces, and infusion pump total product life cycle.\nThis seminar on medi
 cal device software risk management aims to address the following ques
 tions:\n\nHow can a medical device manufacturer or healthcare informat
 ion system provider overcome these technical as well as regulatory com
 pliance challenges?\nWhat are the resources and tools available?\nWhat
  are the industry’s best practices?\nWhat are FDA’s latest updates
  on medical device software best practices?\n\nDuring this two day cou
 rse, the instructor will also introduce the standards and guidance rel
 evant to medical device software, discuss the FDA’s updates on softw
 are risk management, and provide industry best practices including tec
 hniques and tools to achieve compliance and effectively assure medical
  device software safety.\n\nLearning Objectives:\nUpon completing this
  course on managing software risk in medical device, participants will
  be able to:\n\nUse FDA’s latest research on medical device software
  best practices\nGet an overview of software risk management related s
 tandards and guidance including:\nISO 14971:2007 and EN ISO 14971:2012
 , IEC 62304 Medical Device Life Cycle Process, IEC TR 80002-1 Applicat
 ion of ISO 14971 for Software\nFDA Guidance on Mobile Medical Applicat
 ions, Cybersecurity in Medical Devices, Infusion Pump Total Product Li
 fe Cycle\n\n\nLearn techniques and best practices on how to:\nidentify
  software related risks\nidentify software risk control and mitigation
  measures\nassess and evaluate risk contributed/caused by software (pr
 e-market and post-market field issues)\nassure the completeness and ad
 equacy of risk management\ncommunicate risk management information thr
 oughout the life of the product\n\n\nUnderstand key success factors fo
 r effective software risk management\n\nWho will Benefit:\nThis course
  will be beneficial for the personnel in medical device companies. The
  following job titles/ positions will benefit from attending this semi
 nar:\n\nSoftware/System Engineers/Managers/Directors\nQA/RA members/Ma
 nagers/Directors\nRisk Management Engineers/Managers/Directors\nHospit
 al Biomedical Engineers\nHospital Risk Managers\nRegulators of governm
 ent or notified bodies\nCompliance Officers\n\n\nFor more information 
 visit https://medtechiq.ning.com/events/medical-device-software-risk-m
 anagement-cybersecurity-and
DTSTART;TZID=America/New_York:20140313T083000
DTEND;TZID=America/New_York:20140314T130000
CATEGORIES:medical
LOCATION:Boston Marriott Copley Place
WEBSITE:http://www.complianceonline.com/ecommerce/control/seminar?prod
 uct_id=80169SEM&?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/seminar?product_
 id=80169SEM&?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
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