ISO 14971 Risk management for medical devices

About the Event

Overview: Gaps, incorrect or incomplete implementation of safety functionality 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 devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. 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. Who will benefit: Following personnel will benefit from the course: • Senior quality managers • Quality professionals • Regulatory professionals • Compliance professionals • Project managers • Design engineers • Software engineers • Process owners • Quality engineers • Quality auditors • Medical affairs Course Outline/Agenda: Day One: Lecture 1: Introduction into Risk Management and Quality System Integration Lecture 2: Risk Management to ISO 14971:2012 Day Two: Lecture 3: Usability and Risk Management Lecture 4: Software Risk Management (IEC62304 / FDA software reviewers' guidance) Lecture 5: Software Risk Management (IEC62304 / FDA software reviewers' guidance) Lecture 6: Safety / Assurance case Instructor/Speaker Profile: Markus Weber is owner and Principal Consultant with System Safety, Inc. He specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding his consulting company, he was a software safety engineer for the German approval agency, TUV. Date, Venue and Price: Location: Zurich, Switzerland Date: August 14th & 15th, 2014 Venue: Hilton Zurich Airport Address: Hohenbuehlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland Price: $1595.00 (Seminar for One Delegate) Discount: Register now and save $200. (Early Bird) Until July 15, Early Bird Price: $1,595.00, From July 16 to August 12, Regular Price: $1,795.00 Want to register by Wire Transfer? Please call any of our representatives on 1800 447 9407 to help you completed the transfer. Contact Information: John Robinson Toll free: 800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Live Chat - Online Help Desk: http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA For More Info on This Seminar Kindly Go through the Below Link: http://bit.ly/RiskManagementISO14971