Time: February 15, 2018 at 9am to February 16, 2018 at 6pm
Location: Courtyard By Marriott Dallas DFW Airport North/Irving
Street: Dallas, TX
City/Town: Dallas, TX
Website or Map: http://www.globalcompliancepa…
Event Type: regulatory, and, compliance, seminars
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Dec 7, 2017
Gaps, incorrect or incomplete implementation of software can 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 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 critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). 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.