Seminar on Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance at San Diego

Markus Weber, Principal Consultant with System Safety, Inc., will host the seminar at San Diego on October 4 and 5. Participants of this RAPS-approved seminar can earn up to 12 RAC points.

San Diego, CA (prHWY.com) August 21, 2012 - Summary:
GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, "Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance". Markus Weber, Principal Consultant with System Safety, Inc., will host the seminar at San Diego on October 4 and 5. Participants of this RAPS-approved seminar can earn up to 12 RAC points.
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Course Agenda:
This course is a bird's eye view of risk management pertaining to ISO14971, IEC62304 and IEC60601-1: 2005 Compliance. This seminar takes a comprehensive look at the compliance issues relating to ISO14971, IEC62304 and IEC60601-1:2005.
ISO14971 relates to medical safety of a medical device for its intended purpose. Medical device manufacturers are required to take measures to remove risks or at least reduce them to the extent possible. The process through which they are required to do this is detailed in ISO 14971.
On the other hand, IEC62304 is an international standard for medical device software and software lifecycle processes. This document lays out the specificities of lifecycle requirements for the development of both software within medical devices and medical software.
IEC60601-1:2005 deals with risk assessment of a host of aspects relating to medical devices. This standard's 2005 version is its third, and has many revisions over the previous edition.
This seminar details all these standards and explains how they can be applied to risk management in medical devices. In particular, the cross-standard and practical means to integrate activities to cover all three requirements documents is presented. This forms the critical aspect of this course.
---------------------------------------------------------------------------------------------------------------Course Description:
Day 1 -October 4, 2012
Lecture 1 (ISO 14971):
o Risk Management Planning
o Risk Management Life Cycle
o Hazard Identification
o Hazard Domains
o Hazard Latency Issues
o Risk Rating Methods
o Initial (unmitigated) Risk Assessment
o Mitigation Strategies and Priorities
o Mitigation Architectures
Lecture 2 (ISO 14971):
o Alarm Systems as Mitigations
o Risk Control Bundles
o Post Mitigation Risk
o Residual Risk
o Safety Integrity Levels
o Usability as Hazard Source and Mitigation
o Safety Requirements
o Hazard Mitigation Traceability
o Verification Planning
o Architectures, Redundancy and Diversity
o Failure Mode and Effect Analysis / FTA
o Verification Strategies
o System Validation / Mitigation Validation
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Day 2 -October 5, 2012
Lecture 3 (IEC60601-1:2005)
o References to Risk Management
o Section 4 Risk Related Issues
o Compliance for Non-Software Related Issues
o The IEC TRF (technical report form)
o Special PEMS Issues
o PEMS and IEC62304
Lecture 4 (IEC62304)
o Critical Software Issues
o Software Hazard Mitigation Strategies
o Software Item, Unit and System Definition
o Software Failures as Hazard Sources
o Software Requirements and Design Specification
o Software Tools and Development Environment
o Software Unit and Integration Testing
o Real-Time System Challenges
o Software Verification and Validation
o Mitigation Traceability and Effectiveness
About the 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 an 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.
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DATE AND VENUE:
October 4 and 5, 2012
Seminar Timings: 8am to 5pm EDT
Place: San Diego
Venue: Courtyard San Diego Mission Valley/Hotel Circle
595 Hotel Circle South * San Diego, California 92108 USA
Price -$ 1295 if booked up to August 31; $1495 if booked between September 1 and October 3; Register for 4 Participants to Get 1 Free Pass. Discounts offered for multiple registrations. Please contact Customer Care at 1800 447 9407
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Contact Information:

Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/
GlobalCompliancePanel
NetZealous
1000 N West Street,
Suite 1200, Wilmington,
DE 19801.USA

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Tag Words: fda compliance issues, iec60601, iec62304, iso14971, risk management, mitigation risk, hazard source

Categories: Medical

Press Release Contact
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
GlobalCompliancePanel
NetZealous

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