Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management
Thursday 14 August, 8:30 AM 2014 to Friday 15 August, 4:30 PM 2014
Hohenbühlstrasse 10, 8152 Opfikon, Switzerland (View Map)


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:

The course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner's perspective.

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. 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. Over the last 25 years Mr. Weber has helped hundreds of companies, from startups to Fortune 500 firms, to design safe medical devices. He trained hundreds of professionals on four continents in practical risk management and system safety methodologies. He frequently conducts webinars, in-person seminars, corporate training and he teaches Medical Device Risk Management the University of California Irvine Extension. He can be reached at

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


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August 2014
08:30   to    16:30
Day 1 Agenda/Outline
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
Tips and tricks

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
Hohenbühlstrasse 10, 8152 Opfikon, Switzerland (View Map)
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