BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:71532 DTSTAMP:20260519T175112Z SUMMARY:Applying ISO14971 and IEC62304 DESCRIPTION:Overview:\nGaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively p erformed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test crit ical medical devices in a regulatory compliant environment. This cours e will additionally address the software risk management and the resul ting interfaces to device level risk management.\nTo comprehensively s ummarize all risk related activities and to demonstrate the safe prope rties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information toge ther in one place. This documentation will most likely become mandator y for all devices (currently only required for FDA infusion pump submi ssions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.\nWho Will Benefit: \nThe course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirem ents to the medical device development cycle. Risk management has beco me the method of choice to ensure an effective and safety oriented dev ice development. International consensus, reflected in globally applic able standard requirements, has led to risk management being a mandato ry component of almost any activity in the medical device industry.\nT he course will emphasize the implementation of risk management into th e development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly imp ortant software and usability related issues of critical systems. It w ill help to comply with regulatory requirements with minimized overhea d and resource burden. To make the combines effort to design, implemen t and verify a safe device transparent the concept of an assurance cas e will be introduced.\nThe course is mainly based on international con sensus requirements such as ISO14971, IEC62366 and IEC62304. It will c over European (MDD), US (FDA) and international risk management requir ements from a regulatory and practitioner's perspective.\n \n \n \n Location: San Diego, CA Date: March 9th & 10th, 2017 and Time: 9:00 A M to 6:00 PM\n \nVenue: Four Points by Sheraton San Diego Downtown\nA ddress: 1617 1st Avenue - San Diego, California, 92101 - United States \n \nPrice:\n \nRegister now and save $200. (Early Bird)\n \nPric e: $1,295.00 (Seminar Fee for One Delegate)\n \n Until January 31, E arly Bird Price: $1,295.00 from February 01 to March 07, Regular Price : $1,495.00\n \nRegister for 5 attendees   Price: $3,885.00 $6,475. 00 You Save: $2,590.00 (40%)*\n \nQuick Contact:\nNetZealous DBA as G lobalCompliancePanel\n \nPhone: 1-800-447-9407\nFax: 302-288-6884\nEm ail: support@globalcompliancepanel.com      \n\n\nFor more inform ation visit https://medtechiq.ning.com/events/applying-iso14971-and-ie c62304 DTSTART;TZID=America/New_York:20170309T090000 DTEND;TZID=America/New_York:20170310T180000 CATEGORIES:compliance, training, and, latest, information LOCATION:San Diego, CA WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p roduct_id=900750SEMINAR?channel=mailer&camp=Seminar&AdGroup=medtechiq_ March_2017_SEO URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ ct_id=900750SEMINAR?channel=mailer&camp=Seminar&AdGroup=medtechiq_Marc h_2017_SEO CONTACT:800-447-9407 ORGANIZER:NetZealous DBA as GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562014921?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR