Medical Device Architecture - Design for Safety: 2-Day In-Person Seminar training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Medical Device Architecture - Design for Safety: 2-Day In-Person Seminar  

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Senior quality managers, Compliance professionals, Project Managers, System architects, Software engineers, Design engineers, Quality engineers

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Seminar Summary:

This two day interactive course will also address the basic risk management methods and risk related methodologies like FMECA that significantly influence the architectural design. (see full course description)

 

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Training Course Syllabus:


Medical Device Architecture - Design for Safety: 2-Day In-Person Seminar  -  Medical Device Compliance / Regulations Training Seminar

By: Markus Weber, Principal Consultant, System Safety, Inc.

Course Description:

In order to design safe and efficacious medical devices, many detailed design decisions will have to be made, documented and verified. The single most effective method to achieve a high level of safety and decrease the verification and testing effort is the correct decomposition and architecture of any system. Effective architectures not only allow achieving safe devices but also minimize the lifecycle cost of the device by reducing regression testing after changes. Smart allocation of user interface functions and separation of safety functionality will allow the use of graphical user interfaces without compromising safety or complexity.

This medical device design course will help attendees gain a basic understanding of failure types, failure modes and failure rates. Based on the failure behavior, different architectural approaches like redundancy, diversity and supervisory architectures will be discussed. Special emphasis is placed on risk and risk control allocation into architectural structures and the effect on overall design and lifecycle cost will be discussed.

This two day interactive course will also address the basic risk management methods and risk related methodologies like FMECA that significantly influence the architectural design.


Medical Device Architecture - Design for Safety Course Outline:

Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Introduction
What is Architecture?
Failures as cause for hazards
Overt failures
Hidden (covert) failures
Single fault model
Random failures
Stress / Strength models
Design margins
Failure rates
Failure modes
Detectability
Systematic failure
Root causes
Avoidance strategies
Architectural decomposition
Allocation of functionality
Allocation of risk mitigation
Interfaces
Channel Structures
Single channel systems
Multi (dual) channel systems
Control / monitoring systems
Common cause failures
Common sources
Impact and mitigation
Diagnostics
Start-up diagnostics
Run-time diagnostics
Diagnostic coverage
Active vs. passive diagnostics
Questions & answers / detailed discussion based on attendant’s examples


Day Two (8:30 AM – 4:30 PM)

Risk management concepts
When to use
Hazards and harms
Time constraints
Definition of risk control measures
Effectiveness of risk control measures
Weaknesses of the methodology
Failure Mode and Criticality Analysis
When to use (lifecycle)
Qualitative / quantitative analysis
Safety failure fraction
Differences to risk analysis
Weaknesses of the methodology
Software architectures
Documentation requirements
How to verify software architecture?
Interfaces and interference
Risk based verification
Allocation as driver for verification effort
Interference and dependencies
Lifecycle costing
Practical tips and tricks
Q&A

Seminar Summary:

This two day interactive course will also address the basic risk management methods and risk related methodologies like FMECA that significantly influence the architectural design. (see full course description)

print this agenda print agenda for the Medical Device Architecture - Design for Safety: 2-Day In-Person Seminar training seminar

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