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Applying ISO14971 and IEC62304

Zoom in  Zoom out Publish date: 2013-06-20   Hits: 169   Status: Status
Date 2013-08-01 to 2013-08-02
City San Diego
Address 1646 Front Street San Diego CA 92101
Exhibition hall Courtyard Chicago Downtown Magnificent Mile
Sponsor GlobalCompliancePanel
Undertaker GlobalCompliancePanel

Event Description

This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented.

Course Outline:

Day 1 - 01st August 2013

Lecture 1: (ISO 14971):

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


Lecture 2: (ISO 14971):


Alarm Systems as Mitigations

Risk Control Bundles

Post Mitigation Risk

Residual Risk

Safety Integrity Levels

Usability as Hazard Source and Mitigation

Safety Requirements

Hazard Mitigation Traceability

Verification Planning

Architectures, Redundancy and Diversity

Failure Mode and Effect Analysis / FTA

Verification Strategies

System Validation / Mitigation Validation

Day 2 - 02nd August 2013

Lecture 3: (IEC60601-1:2005):


References to Risk Management

Section 4 Risk Related Issues

Compliance for Non-Software Related Issues

The IEC TRF (technical report form)

Special PEMS Issues

PEMS and IEC62304

Lecture 4: (IEC62304):

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

Who Will Benefit:

Project Managers

Regulatory / Compliance Managers and Specialists

Quality Assurance Managers

System Engineering

Hardware Engineers

Software Engineers

About Speaker: 

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: San Diego | August 01 & 02, 2013 | 9 AM to 6 PM PDT

Venue: Doubletree by Hilton San Diego Downtown

Venue Address: 1646 Front Street San Diego CA 92101 


Price: $1,295.00

Register now and save $200. (Early Bird)

Until June 30, Early Bird Price: $1,295.00

From July 01 to July 30, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884




Event Link -


Net Zealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

Contact information
Contact: Jihn Robinson
Address: 1646 Front Street San Diego CA 92101
Tel: 1800 447 9407
Fax: 302 288 6884
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