Seminar on Medical Device Software Development at Boston, MA

Overview:

This seminar is mainly based on the IEC62304:2006 standard and will introduce the main elements and requirements for the development of modern software systems for medical devices. Emphasis is placed on understanding the underlying principles that generate the requirements of the standard, to understand strengths, the shortcomings and weak parts of the standard and give practical, proven guidance on how to implement the requirements necessary for regulatory approval. This seminar goes beyond teaching the mere content of the standard, but will provide the toolset to understand the underlying engineering principles that allow a justifiable interpretation of potential ambiguities of regulatory requirements. Understanding the basic principles of risk management, the failure modes of software, the architectural approaches available to mitigate software failures and the understanding of test methodologies are vital components to understand the 'spirit' of the requirements.

Software risk management has to be embedded into the bigger scope of overall risk management. Therefore, this course will additionally link to the system level risk management and the resulting interfaces to software. Risk probability and the impact on software based risk reduction will be discussed.

Who will benefit:

This course is developed to provide valuable assistance to all regulated companies that need to understand their software development processes including companies:

·         Senior Quality Managers

·         Quality Professionals

·         Regulatory Professionals

·         Compliance professionals

·         Project Managers

·         Software Project Managers

·         Design Engineers

·         Software Engineers

·         Process Owners

·         Quality Engineers

·         Quality Auditors

Agenda:

Day One

Lecture 1: Historic Perspective

·         IEC60601-1-4

·         FDA Software Reviewers Guidance

Lecture 2: Other Industries

·         Aerospace

·         Automotive

·         PetroChem

Lecture 3: Understanding Software failure modes

·         Random Faults

·         Systematic Faults

·         Common cause faults

·         User Faults

Lecture 4: Understanding Software and Hardware

·         Coupling mechanisms

·         Shared resources

·         Interference free concept

Lecture 5: What is Firmware?

·         FPGA / VHDL / ASICS

·         Low level / non loadable / BIOS

·         Microcode

Lecture 6: Software and Risk Management
Hazardous situations and Hazard causes

·         Risk assessment

·         Mitigation and Risk reduction

·         Software fault probability

Lecture 7: Mitigation Strategies for Software Faults

·         Fault avoidance strategies

·         Fault control strategies

Lecture 8: Development Lifecycle Models

·         Waterfall

·         Evolutionary

·         V-Model

·         Agile, Extreme Programming, etc.

Lecture 9: Development Process (IEC60304)
Planning

·         Mandatory planning elements

Specifying

·         Good / bad requirements

Architectures

·         RTOS

·         Round robin

·         General purpose OS

·         Segmentation and allocation

Implementing

·         Implementation Tools

·         Implementation Management

·         Code documentation

·         Coding standards

·         Debugging

Verifying

·         Unit Verification

·         Architecture Verification

·         System Verification

·         System Validation (not in IEC62304)

·         Verification Techniques

·         Testing

·         Traceability

·         Release

Day Two

Lecture 1: Problem Resolution Process (IEC60304)

·         Identification / Planning

·         Authorization

·         Verification

·         Special regression test issues

Lecture 2: Software Risk Management Process (IEC60304)

·         Risk identification

·         Software criticality classification

·         SOUP issues

Lecture 3: Software Configuration control (IEC60304)

·         When, what and why

Lecture 4: Software Maintenance Process (IEC60304)

·         Change classes

·         Specification

·         Authorization

·         Verification / Regression testing

Lecture 5: SOUP and Legacy software

·         Integration of off-the-shelf software components

·         How to treat legacy software

Lecture 6: Software and System Aspects (IEC60601-1:14)

·         Software development with close hardware integration

Lecture 7: Special Issues

·         Real time systems

·         Mobile computing

·         Legacy software

·         Communication

o    Zigbee (mesh networking)

o    Bluetooth (P2P wireless)

o    RS252 / serial (old P2P)

o    TCP/IP - UDP (global/local network)

o    USB (Wired P2P)

o    WiFi (Wireless global/local network)

Lecture 8: Software Security

·         Firewalls

·         Encryption

·         Proprietary protocols

Speaker:

Markus Weber is the owner and Principal Consultant with System Safety, Inc. He specializes in safety engineering and risk management for critical medical devices. With his background in embedded systems engineering (MSEE) Mr. Weber provides safety and regulatory compliance consulting to multiple industries for more than 20 years. Before founding his consulting company, 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. He teaches webinars, seminars and university courses on a regular basis.

Location: Boston, MA        Date: May 21st & 22nd, 2015        Time: 9 AM to 6 PM 
Venue: WILL BE ANNOUNCED SOON

Price: $1,295.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird)

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

From May 01 to May 19, Regular Price: $1,495.00

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Registration Link - http://bit.ly/1ymqqjI