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Implementing Risk Management Principles and Activities within a Quality Management System

2/27/2014 9:00 AM - 2/28/2014 6:00 PM


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.

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


Day One

Lecture 1: Introduction into Risk Management and Quality System Integration

Lecture 2: Risk Management to ISO 14971:2012

Day Two

Lecture 3: IEC 60601-1 3rd edition (incl. A1)

Lecture 4: Usability Risk Management (IEC62304:2006 / FDA usability Guidance)

Lecture 5: Software Risk Management (IEC62304 / FDA software reviewers' guidance)

Speaker Profile:

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 start-ups to Fortune 500 firms.

Venue, Date and Price:

Date: 27th & 28th February 2014

Location: Singapore

Venue: Will Be Announced Soon

Price: $1595.00

Discount: Register now and save $200. (Early Bird)

Until January 25, Early Bird Price: $1,595.00

From January 26 to February 25, Regular Price: $1,795.00

Contact Information:

John Robinson

Toll free: 1800 447 9407

Fax: 302 288 6884




NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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