San Diego, California (PressExposure) July 17, 2013 -- What the seminar is about:
This seminar relates to issues to consider for complying with ISO 14971, IEC 62304 and IEC 60601-1:2005, the global standards governing regulations and guidelines for software in medical devices. It particularly focuses on the cross-standard and practical means to integrate activities to cover these requirements documents. Since it is software that is the engine of a medical device; its regulation is necessary to enable it to perform its intended purposes, and this seminar will be about how to help organizations do this.
The ISO 14971
ISO 14971 is the global regulatory compliance standard aimed at ensuring the medical safety of a medical device. The foundational notion on which this standard is built is that medical device manufacturers have to take measures to anticipate and eliminate, or at least lessen risks to the best extent that they possibly can. ISO 14971contains the necessary processes by which these are to be done.
The IEC 62304
The IEC 62304 complements ISO 14971. It is the global standard for the development of medical software, as well as software within medical devices. This standard relates to medical device software and their software lifecycle processes.
For IEC 62304, the software-related issues that form this standard's bases are software specification, architectures and the resulting design documentation. Naturally, the test of successful compliance of a medical device company with all the regulatory requirements is in how effectively it implements these standards.
The IEC 60601-1:2005
This seminar will also cover IEC 60601-1:2005, the standard which relates to risk assessment of several aspects of medical devices. The current version of this standard, arrived at in 2005 is its third.
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 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.
The seminar will have the following agenda:
Day 1 -Agenda
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
Day 2 -Agenda
Lecture 3: (IEC 60601-1:2005):
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 IEC 62304
Lecture 4: (IEC 62304):
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
This seminar will benefit:
a. Project Managers
b. Regulatory/Compliance Managers and Specialists
c. Quality Assurance Managers
d. System Engineering
e. Hardware Engineers
f. Software Engineers
Venue, date and timings: The venue for this seminar is the DoubleTree by Hilton San Diego Downtown, 1646 Front Street, San Diego CA 92101. The seminar will be on August 1 and 2, from 9 A.M to 6 P.M PDT.
Price: $1,495.00 per participant. Discounts are available for group participation in the following manner:
For two attendees: 10% discount
For three to six attendees: 20% discount
For seven to 10 attendees: 25% discount
For more than 10 attendees: 30% discount
To avail the above group discounts, all the participants should register by making a single payment.
Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar.
Call our representative on 1800 447 9407 to have your seats confirmed.
Toll free: 1800 447 9407
Fax: 302 288 6884
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