2-day In-person Seminar on Medical Device Software Risk Management and Assurance Case at Boston, MA


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 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 device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.
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.

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 to Implement Risk Management into ISO13485
• Tips and tricks
Lecture 2: Risk Management to ISO 14971:2012
• Risk Management Planning
• Risk Management Life Cycle
• Hazard Identification
• Initial (unmitigated) Risk Assessment
• Mitigation Strategies and Priorities
• Mitigation Architectures
• Post Mitigation Risk
• Residual Risk
• European special requirements (Z-Annexes)
• Safety Requirements
• Hazard Mitigation Traceability

Day 2 – Agenda

Lecture 3: 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
• 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
• Q&A
Lecture 4: Safety / Assurance case
• Safety classes
• Documentation of Basic Safety
• Documentation of essential performance
• External safety
• Verification of safety properties
• Assurance case vs. Risk Management Report
• Tips and Tricks/li>
• Q&A

Who Will Benefit:

The course 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. 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.
• Senior Quality Managers
• Quality Professionals
• Regulatory Professionals
• Compliance Professionals
• Project Managers
• Design Engineers
• Software Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Medical Affairs


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: Location: Boston, MA Date: 19th & 20th, June 2014 Time: 9 AM to 6 PM EDT
Price: $1,295.00
Register now and save $200. (Early Bird)
Until May 20, Early Bird Price: $1,295.00
from May 21 to June 17, Regular Price: $1,495.00

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