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Overview:
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
Legal Professionals
Agenda:
Day 1 Schedule:
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
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
Q&A
Day 2 Schedule:
Lecture 1: Usability and Risk Management
Use errors as hazard source
User intervention as hazard mitigation
Usability engineering lifecycle
Application specification
Usability Specification
Frequently used functions / primary operating functions
Usability verification / validation
Upcoming changes IEC62366:2014
Lecture 2: 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
Lecture 3: Software Risk Management (IEC62304 / FDA software reviewers' guidance):
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
Lecture 4: Safety / Assurance case
Safety classes
Basic Safety / Environment
Essential performance
Documentation of Basic Safety
Electrical Safety
Mechanical Safety
EMC / RFI safety
Safety margins
Documentation of essential performance
What is essential performance?
Device architectures and mitigation allocation
Device specific mitigations
Software mitigations
External safety
User intervention and alarms
Organizational measures
Levels of protection concept
Verification of safety properties
Type testing
Sample testing
Software verification testing
Inspections
Analyses
Assurance case vs. Risk Management Report
General safety and hazard avoidance
Device / application specific issues
Tips and Tricks
Q&A
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: Zurich, Switzerland Date: May 18th & 19th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland
Price:
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until April 10, Early Bird Price: $1,695.00 from April 11 to May 16, Regular Price: $1,895.00
Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*
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