[ÖRFÍ] Fw: Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management: 2-day In-person Seminar

[Linda Helgadóttir]

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----- Forwarded by Linda Helgadóttir/RLSH/Landspitali/IS on 18.09.2014 
15:44 -----

From:   "Conferences and Seminars" 
<training at info.globalcompliancepanel.com>
To:     lindah at landspitali.is
Date:   18.09.2014 09:29
Subject:        Applying ISO14971:2012 and IEC62304 - A Guide to Practical 
Risk Management: 2-day In-person Seminar



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Seminar 

2-day In-person Seminar on
Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management


By Markus Weber 




REGISTER NOW





Price: $1,595.00 (for 1 attendee) Register now and save $200. (Early Bird)
Location : London, UK | October 27th & 28th, 2014 | 9 AM to 6 PM 
Venue: WILL BE ANNOUNCED SOON 
Course "Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk 
Management" has been pre-approved by RAPS as eligible for up to 12 credits 
towards a participant's RAC recertification upon full completion.




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. 
Who Will Benefit: 
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
About Speaker 
Markus Weber 
Principal Consultant, System Safety Inc. 

Markus Weber s 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. 
Over the last 25 years Mr. Weber has helped hundreds of companies, from 
startups to Fortune 500 firms, to design safe medical devices. He trained 
hundreds of professionals on four continents in practical risk management 
and system safety methodologies.

Agenda: 
Day 1
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
Architectures, Redundancy and Diversity
Failure Mode and Effect Analysis
Tips and Tricks
Q&A 

Day 2 
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
Usability verification / validation
Upcoming changes IEC62366:2014
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
Software Tools and Development Environment
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
Upcoming changes in IEC62304:2014
Tips and Tricks
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
Tips and Tricks
Q&A




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