Overview:

Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycle has to be demonstrated. This course introduces the major components necessary to achieve global regulatory compliance and approvability. The main emphasis is on European and US regulation. A practical path to implanting a successful risk management system across different subsystems will be presented. The main issues covered are risk management, compliance with IEC60601-1, usability engineering and software risk management. The course is based on 20+ years of experience in the medical device industry and emphasizes practical implementation issues and not just theoretical background. If your company is developing devices for international markets this seminar will give you the information needed to design and document a globally acceptable design lifecycle.

Why you should attend:

Since risk management is a wide spanning activity involving management, engineering, QA/RA, clinical affairs and manufacturing / sustaining engineering, the seminar addresses a broad audience and generates a common understanding of risk management principles and methods. Some elements of the agenda a specific to design engineering but a shared knowledge of risk management principles is essential to successfully implement a working risk management system.

Course Outline: Day 1 – Agenda Lecture 1: Introduction into Risk Management and Quality System Integration Why risk management? Risk Management Lifecycle and stakeholders Risk Management Benefits How I to implement Risk Management into ISO13486 Q&A

Lecture 2: Risk Management to ISO 14971:2012 Risk Management Planning Risk Management Life Cycle Hazard Identification

Day 2 – Agenda Lecture 3: IEC 60601-1 3rd edition (incl. A1) References to Risk Management Section 4 Risk Related Issues Compliance for Non-Software Related Issues The IEC TRF (technical report form)

Lecture 4: Usability Risk Management (IEC62304:2006 / FDA usability Guidance) Use errors as hazard source User intervention as hazard mitigation Usability engineering lifecycle Application specification

Lecture 5: 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

Who Will Benefit: This 2-day course is particularly relevant to managers, supervisors, QA / RA and design/system engineers. Even experienced personnel will benefit from the across industry perspective and the illustration of standard practices that only a presenter with extensive experience in more than 100 projects can provide. Specific positions that would benefit are: Project managers Risk managers Engineering management Quality Assurance personnel Regulatory and Compliance professionals responsible for FDA / notified body interactions System and design Engineers Software Engineers Usability Engineers Verification / validation personnel Production Managers ABOUT SPEAKER – Markus Weber Principal Consultant, System Safety Inc.

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.

Location: Singapore

27th & 28th February 2014

9:00AM-6:00PM Venue: Mandarin Orchard Singapore Address: 333 Orchard Road, Singapore 238867 Price: $1,595.00 Discount: Register now and save $200. (Early Bird) Until January 25, Early Bird Price: $1,595.00 from January 26 to February25, Regular Price: $1,795.00 Contact Information: Event Coordinator Call: +65-3158-3448 Fax: 302-288-6884 Email: Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT – http://www.globalcompliancepanel.com/chat/client.php Event Link: http://bit.ly/1dcfswj NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407