Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management | August 14, 2014 9:00 AM - August 15, 2014 6:00 PM |

Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management

Event Summary

August 14, 2014 - August 15, 2014
Zurich, CA 8152
August 14, 2014 9:00 AM
August 15, 2014 6:00 PM
[email protected]
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This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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.

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
• Verification Planning

Day 2 – Agenda

Lecture 3: 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
Lecture 4: 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
Lecture 5: 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
Lecture 6: 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

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


Markus Weber
Principal Consultant, System Safety Inc.
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.

Location: Zurich, Switzerland Date: August 14th & 15th, 2014 Time: 9 AM to 6 PM
Venue: Hilton Zurich Airport

Address: Hilton Zurich Airport, Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland

Price: $1,595.00

Register now and save $200. (Early Bird)
Until July 15, Early Bird Price: $1,595.00
from July16 to August 12, Regular Price: $1,795.00

Contact Information:

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