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8/9/2019 Medical Device Software Development-SFO-CA.pdf
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SPEAKER
Global
CompliancePanel
2-day In-person Seminar:
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
Knowledge, a Way Forward…
Medical Device Software Development
Markus Weber Principal Consultant, System Safety Inc.
Markus Weber is 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, specically 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 rms, to design safe medical devices.
OVERVIEW
Course has been pre-approved" "Medical Device Software Development
by as eligible for up to 12 credits towards a participant's RACRAPS
recertification upon full completion.
Markus Weber
August 6th & 7th, 2015
SFO, CA
9 AM to 6 PM
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 require-
ments 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.
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Global
CompliancePanel
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
Knowledge, a Way Forward…
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
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
Inspection
Analysis / Simulation
Symbolic execution
Test tools (VectorCAST, etc.)
Testing
Black Box
White Box
Exception / Equivalence classes / Stress testing
Boundary conditions
Traceability
Purpose and techniques
Release
Baseline / regression testing
Known anomalies management
Archive Items / repeatability / re-creatability
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Global
CompliancePanel
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
Knowledge, a Way Forward…
AGENDA
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
Specification
Authorization
Verification / Regression testing
Lecture 6: SOUP and Legacy software
Software development with close hardware integration
Specification
Authorization
Verification / Regression testing
Lecture 7: Special Issues
Real time systems
Mobile computing
Legacy software
Communication
Zigbee (mesh networking)
Bluetooth (P2P wireless)
RS252 / serial (old P2P)
TCP/IP - UDP (global/local network)
USB (Wired P2P)
WiFi (Wireless global/local network)
Lecture 8: Special Issues
Firewalls
Encryption
Proprietary protocols
Senior Quality Managers
Quality Professionals
Regulatory Professionals
Compliance professionals
Project Managers
Software Project Managers
Design Engineers
Software Engineers
Process Owners
Quality Engineers
Quality Auditors
Who will benet:
8/9/2019 Medical Device Software Development-SFO-CA.pdf
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Global
CompliancePanel
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
Knowledge, a Way Forward…
1. Learning Objectives
2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.
5. Special price on future purchase of web based trainings.
6. Special price on future consulting or expertise services.
7. Special price on future seminars by
GlobalCompliancePanel.
8. Seminar Kit – includes presentation handout, ID card,
brochure, trainings catalog, notepad and pen.
9. Networking with industry's top notch professionals
What you get
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the register
now link
Check: Kindly make the check payable to NetZealous DBA
GlobalCompliancePanel and mailed to 161 Mission Falls
Lane, Suite 216, Fremont, CA 94539, USA
PO: Please drop an email to
[email protected] or call the our toll
free +1-800-447-9407 for the invoice and you may fax the
PO to 302 288 6884
Wire Transfer: Please drop an email to
[email protected] or call our toll free
+1-800-447-9407 for the wire transfer information
Payment Options:
Get fabulous discounts by participating in groups of two or more.Price for One Delegate pass Price: $1,645.00
Register now and save(Early Bird) (Early Bird) Price$200.
Pricing List
**Please note the registration will be closed 2 days (48 Hours) prior to
the date of the seminar.
Group participations
AttendeesNo Discount
1 2 Attendees
2 3 to 6 Attendees
3 7 to 10 Attendees
4 10+ Attendees
10% off
20% off
25% off
30% off
Register Now