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.



Global

CompliancePanel



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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CompliancePanel



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


Lecture 6: SOUP and Legacy software

Software development with close hardware integration

Specification

Authorization


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:



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CompliancePanel



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

http://localhost/var/www/apps/conversion/tmp/scratch_7/[email protected]

http://localhost/var/www/apps/conversion/tmp/scratch_7/[email protected]

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Medical Device Software Development-SFO-CA.pdf

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