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
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 [email protected]

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),
6201 America Center Drive Suite 240
San Jose, CA 95002
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 @ [email protected]

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.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • 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: [email protected] 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 Zurich, Switzerland

    Kunsthaus Zurich

    Kunsthaus Zurich

    The Kunsthaus is Zurich's most important art museum and one of the most famous in Europe. Although the collection of the Kunsthaus Zürich ranges from Ancient times to the Victorian Era, the Swiss art museum is most noted for its modern and contemporary works from the 19th and 20th centuries. Top exhibits include the Giacometti wing and Rodin's Gate of Hell.

    Bahnhofstrasse

    Bahnhofstrasse

    Widely known as the principal boulevard in Zürich, the Bahnhofstrasse is Zurich's most famous shopping street. Lined with some of the city's most elegant boutiques and top department stores, the Bahnhofstrasse offers a delightful place for a day of shopping amongst some of the world's greatest luxury brands and jewelry stores.

    Zurich Zoo

    Zurich Zoo

    Elephants, rhinos, tigers, penguins and 20 species of monkeys are just some of the more than 360 animal species that can be admired at the Zurich Zoo. In the Masoala Rainforest Hall visitors can experience a piece of Madagascar first hand. A must-see for young and old.

    Limmat River

    Limmat River

    Switzerland's Limmat River is actually part of the Linth river, which continues from Lake Zurich. Zurich is the most famous city located along the Limmat Valley and the Limmat River provides a charming and beautiful waterway to explore the sights of Zurich by boat.

    Fraumunster Church

    Fraumunster Church

    The Fraumünster Church overlooks one of Zurich's oldest squares and markets, the Münsterhof. Tracing its founding back to 853, when it was a Benedictine abbey, the church is home to five famous stained-glass windows by renowned artist Marc Chagall.

    Zurich Old Town

    Zurich Old Town

    Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings

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

    We need below information to serve you better

     

    +1-888-717-2436

    6201 America Center Drive Suite 240, San Jose, CA 95002, USA

    Follow Us

    facebook twitter linkedin youtube

     

    Copyright © 2023 ComplianceOnline.com MetricStream
    Our Policies: Terms of use | Privacy

    PAYMENT METHOD: 100% Secure Transaction

    payment method