Risk Management in Medical Devices Industry (COM) A

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Tampa, FL 33602

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Risk Management in Medical Devices Industry

About this Event



Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.

Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.

By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.

Learning Objectives:

Upon completing this course participants should:

  • Understand the risk management process, the activities, and deliverables as well as the organization framework necessary
  • Be able to Interpret and discuss the requirements of ISO 14971
  • Develop a risk analysis framework document
  • Be able to conduct risk analysis team meetings
  • Recognize how and where to use the various techniques during the design life cycle.
  • Understand how to apply ISO 14971 into development process
  • Know how to document your Risk Management
  • Explain how your Risk Management system fits into quality system and business practices.
  • Perform risk assessments effectively

Seminar Fee Includes:


AM-PM Tea/Coffee

Seminar Material

USB with seminar presentation

Hard copy of presentation

Attendance Certificate

$100 Gift Cert for next seminar

Who Will Benefit:

This course is relevant to managers, supervisors, QA / RA, and design/system engineers. Even experienced personnel will benefit from the "across industry" perspective and the illustration of standard practices that only a presenter with extensive experience in more than 100 projects can provide. Specific positions that would benefit are:

  • Project managers
  • Risk managers
  • Engineering management
  • Quality Assurance personnel
  • Regulatory and Compliance professionals responsible for FDA / notified body interactions
  • System and design engineers
  • Software Engineers
  • Usability Engineers
  • Verification / validation personnel
  • Production Managers


Day 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

Lecture 1: Introduction To Risk Management And Quality System Integration

Why Perform Risk Management?

Historical Perspective

International Regulatory / Statutory Requirements

Risk Management Lifecycle And Stakeholders

Over-Reaching Concept

Integration Into ISO13485

Lifecycle Steps

Risk Management Benefits

Liability Issues

Streamlining Product Development

Improving Product Safety And Quality

How To Implement Risk Management Into ISO13485

SOP Framework

Planning And Execution

Monitoring And Control

Lecture 2: Risk Management To ISO 14971:2012

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

Alarm Systems As Mitigations

Risk Control Bundles

Post Mitigation Risk

Residual Risk

Risk-Benefit Analysis

Safety Integrity Levels

European Special Requirements (Z-Annexes)

Safety Requirements

Hazard Mitigation Traceability

Verification Planning

Architectures, Redundancy, And Diversity

Failure Rates / Modes / Types

Failure Mode And Effect Analysis

Tips And Tricks


Day 02(8:30 AM - 4:30 PM)

Lecture 3: Software And Usability In Risk Management

Software Risk Management (IEC62304 / FDA Software Reviewers' Guidance)

Critical Software Issues

Software Hazard Mitigation Strategies

Software Item, Unit, And System Definition

Software Failures As Hazard Sources

Software Requirements And Design

Software Specification

Tools And Development Environment

Software Unit And Integration Verification / Testing

Real-Time System Challenges

Software Verification And Validation

Mitigation Traceability And Effectiveness

Software Maintenance And Configuration Control

Software Risk Management Process - Integration Into ISO14971

Legacy Software Issues

FDA Documentation Requirements

Tips And Tricks

Lecture 4: Usability And Risk Management (IEC62366-1/-2 / FDA Human Factors Guidance)

Use Errors As Hazard Source

User Intervention As Hazard Mitigation

Usability Engineering Lifecycle

Usability Evaluation Methods

Usability Specification

User Interface Specification

Formative Testing / Summative Evaluation

Usability Verification / Validation

The New Issues In IEC62366-1:2015

Lecture 5: Risk Management Report And Safety Case

Safety / Assurance Case

Safety Classification

Basic Safety / Environment

Documentation Of Basic Safety

Electrical Safety

Mechanical Safety

EMC / RFI Safety

Safety Margins

Documentation Of Essential Performance

What Is Essential Performance?

Device Architectures And Mitigation Allocation

Device Specific Mitigations

Software Mitigations

External Safety

User Intervention And Alarms

Organizational Measures

Levels Of Protection Concept

Verification Of Safety Properties

Type Testing / Sample Testing

Verification Testing



Assurance Case Vs. Risk Management Report

General Safety And Hazard Avoidance

Device / Application Specific Issues

Tips And Tricks



Markus Weber

Principal Consultant, System Safety, Inc.

Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber 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, he 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. He has helped multiple companies, from startups to Fortune 500 firms.

"Please contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:

- Multiple participant discounts

- Price quotations or visa invitation letters

- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)

- Event sponsorships


Service fees included in this listing.


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Tampa, FL 33602

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