Applying ISO14971 and IEC62304: A Guide to Practical Risk Management (Boston, MA, United States – January 19-20, 2017) – Research and Markets


Research and Markets has announced the addition of the “Applying ISO14971 and IEC62304 – A guide to practical Risk Management” conference to their offering.

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 Should Attend:

– 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


Day One

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

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

– Architectures, Redundancy and Diversity

– Failure Mode and Effect Analysis

– Tips and Tricks

– Q&A

Day Two

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

– Documentation of Basic Safety

– Documentation of essential performance

– External safety

– Verification of safety properties

– Assurance case vs. Risk Management Report

– Tips and Tricks

– Q&A

For more information about this conference visit