Course Description:
Risk management has become the method of choice to ensure an effective and safety oriented device development process. 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.
This highly interactive two day seminar on software risk management and compliance will:
- Introduce the main elements of risk management with emphasis on software issues and the application of risk management principles and requirements to the medical device development cycle.
- Cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.
- Introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment.
- Emphasize the implementation of risk management into the development and maintenance process.
- Address the system level issues of risk management as well as the increasingly important software related issues of critical systems.
- Introduce the basic concepts and content of safety assurance cases and illustrate the usefulness for internal and external review of safety related information.
This seminar is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will help to comply with regulatory requirements with minimized overhead and resource burden.
Learning Objectives:
Upon completing this course on software risk management and compliance participants will:
- Understand basic elements of risk management
- Know the meaning of terms like hazard, hazardous situation, hazard cause and harm
- Be able to select proper risk rating methods for a given project
- Know the differences between random failure and systematic failures
- Assess software induced hazards and methods to mitigate them
- Understand the role of software in hazard mitigation
- Be able to apply software development methods to existing projects
- Know how to address legacy software issues
- Establish a software lifecycle model
- Structure and compose a safety assurance case
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
Topic Background:
Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked to the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. 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 (it is currently only required for FDA infusion pump submissions).
Course Outline:
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 4:30 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM Introduction to Risk Management and Quality System Integration
Risk Management to ISO 14971:2012
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Software Risk Management (IEC62304 / FDA software reviewers’ guidance):
Safety / Assurance case
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Meet Your Instructor
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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. Mr. Weber 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, he 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. He has helped multiple companies, from startups to Fortune 500 firms. |
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