“Applying ISO14971 and IEC62304 - A guide to practical Risk Management” at San Diego

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.
FREMONT, Calif. - July 16, 2013 - PRLog -- 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 agenda:

The seminar will have the following agenda:

Day 1 –Agenda

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 –Agenda

Lecture 3: (IEC 60601-1:2005):

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 IEC 62304

Lecture 4: (IEC 62304):

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


For whom:

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.


Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884


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