ApApplying ISO14971 / IEC62304 / IEC62366-1 A Practical Guide On How To Implement Risk Management
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This document outlines a two-day in-person seminar in Singapore on applying ISO 14971 and IEC 62304 for effective risk management in the medical device industry, scheduled for May 22nd and 23rd, 2017, at a cost of $1,695 per delegate. Led by Markus Weber, a principal consultant with extensive experience in safety engineering, the seminar aims to provide practical knowledge on risk management integration into quality systems, particularly for active and software-controlled medical devices. The agenda includes lectures on risk management planning, software risk management, and assurance cases, targeting professionals such as quality managers, engineers, and regulatory experts.
ApApplying ISO14971 / IEC62304 / IEC62366-1 A Practical Guide On How To Implement Risk Management
- 1. 2-day In-person Seminar: Knowledge, a Way Forward… Applying ISO14971 and IEC62304 - A guide to practical Risk Management Singapore May 22nd & 23rd, 2017 9:00 AM to 6:00 PM Markus Weber Price: $1,695.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Price Overview : Global CompliancePanel Markus Weber, Principal Consultant with System Safety, Inc., 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 System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms. 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. $8,475.00 Price: $5,085.00 You Save: $3,390.0 (40%)* Register for 5 attendees Principal Consultant, System Safety Inc.
- 2. Global CompliancePanel Agenda: Day One Day Two 2-day In-person Seminar: Applying ISO14971 and IEC62304 - A guide to practical Risk Management Lecture 1: Introduction into Risk Management and Quality System Integration Why risk management? Historical perspective International regulatory / statutory requirements Risk Management Lifecycle and stakeholders Over-reaching concept Integration into ISO13485 Lifecycle steps Risk Management Benefits Liability issues Streamlining product development Improving product safety and quality How to Implement Risk Management into ISO13485 SOP framework Planning and execution Monitoring and control Lecture 1: Usability and Risk Management Use errors as hazard source User intervention as hazard mitigation Usability engineering lifecycle Application specification Usability Specification Frequently used functions / primary operating functions Usability verification / validation Upcoming changes IEC62366:2014 Who will benefit: Senior quality managers Quality professionals Regulatory professionals Compliance professionals Project managers Design engineers Software engineers Process owners Quality engineers Quality auditors Medical affairs Legal Professionals Lecture 2: Software Risk Management (IEC62304 / FDA software reviewers' guidance): Critical Software Issues Software Hazard Mitigation Strategies Software Item, Unit and System Definition Software Failures as Hazard Sources Software Requirements and Design Specification Software Tools and Development Environment Lecture 3: Software Risk Management (IEC62304 / FDA software reviewers' guidance): Software Unit and Integration Testing Real-Time System Challenges Software Verification and Validation Mitigation Traceability and Effectiveness Software Maintenance and Configuration Control Software Risk Management Process integration into ISO14971 Legacy Software issues FDA documentation requirements Upcoming changes in IEC62304:2014 Tips and Tricks
- 3. Lecture 2: Risk Management to ISO 14971:2012 Risk Management Planning Risk Management Life Cycle Hazard Identification Hazard Domains Hazard Latency Issues Risk Rating Methods Initial (unmitigated) Risk Assessment Mitigation Strategies and Priorities Mitigation Architectures Alarm Systems as Mitigations Risk Control Bundles Post Mitigation Risk Residual Risk Safety Integrity Levels European special requirements (Z-Annexes) Safety Requirements Hazard Mitigation Traceability Verification Planning Architectures, Redundancy and Diversity Failure Mode and Effect Analysis Tips and Tricks Q&A Lecture 4: Safety / Assurance case Safety classes Basic Safety / Environment Essential performance Documentation of Basic Safety Electrical Safety Mechanical Safety EMC / RFI safety Safety margins Documentation of essential performance What is essential performance? Device architectures and mitigation allocation Device specific mitigations Software mitigations External safety User intervention and alarms Organizational measures Levels of protection concept Verification of safety properties Type testing Sample testing Software verification testing Inspections Analyses Assurance case vs. Risk Management Report General safety and hazard avoidance Device / application specific issues Tips and Tricks Q&A Agenda: Day One Day Two 2-day In-person Seminar: Applying ISO14971 and IEC62304 - A guide to practical Risk Management Global CompliancePanel
- 4. Global CompliancePanel www.globalcompliancepanel.com Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel What You will get Special price on future seminars by GlobalCompliancePanel. Networking with industry's top notch professionals 7 9 1 Learning Objectives 2 Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. 3 4 5 6 Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 8 Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com 10% 20% 25% 30% 2 Attendees to get offer 3 to 6 Attendees to get offer 7 to 10 Attendees to get offer 10+ Attendees to get offer Group Participation Payment Option 1 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link 2 Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free +1-800-447-9407 for the invoice and you may fax the PO to 302 288 6884 Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free +1-800-447-9407 for the wire transfer information 3 4 2-day In-person Seminar: Applying ISO14971 and IEC62304 - A guide to practical Risk Management