ComplianceOnline

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:
Lunch
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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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
    • Q&A
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
      • Inspections
      • Analyses
    • Assurance Case Vs. Risk Management Report
    • General Safety And Hazard Avoidance
    • Device / Application Specific Issues
    • Tips And Tricks
    • Q&A
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Markus Weber

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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

North End

North End

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church

Old North Church

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading