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Short Course: Medical Device Regulations

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  • Short Course: Medical Device Regulations

    Introduction to Medical Device Regulations

    Monday - Friday, 8:30 - 5:00 p.m.
    January 8-12, 2001
    Dively Executive Education Center
    11240 Bellflower Road
    Case Western Reserve University
    Cleveland, Ohio 44106

    The Biomedical Engineering Department of Case Western Reserve
    University and the Edison BioTechnology Center, with the support of
    other leading Cleveland technology organizations, presents
    "Introduction to Medical Device Regulations," a five-day course on
    navigating medical products through the FDA approval process. The
    course will present a comprehensive overview of the FDA medical
    device regulations and various aspects of the approval process.

    This seminar will cover these key topics :

    … Introduction to FDA and Medical Device Regulations
    … Quality Assurance in Product Development
    … Design Controls: Requirements & Methods
    … Clinical Investigation of Medical Devices
    … Bioresearch Monitoring and Post-Approval Issues

    Course instructors will include regional and national experts from
    government, industry, the legal profession, and trade associations.
    Executives from local medical device companies will speak during
    lunch on the significance of the regulatory process to the
    introduction of new life-saving technologies.

    Who Should Attend?

    The course is designed for individuals involved in the design,
    development and manufacturing of medical devices. The course is also
    an excellent choice for biomedical engineering, medical and law

    NOTE: Student enrollees must have 3rd year or higher status (i.e.,
    juniors, seniors, or graduate students).
    About The Course

    Requirements imposed by the federal government on the healthcare
    industry are comprehensive and complex. They impact all disciplines
    within the corporate and business structure. Regulations enacted by
    The Food and Drug Administration (FDA) influence the development of
    products in the pharmaceutical, medical device, biotechnology and
    healthcare information technology industries. They include all
    products used in the practice of healthcare from diagnosis to
    treatment and ongoing care.

    It is imperative that anyone responsible for designing,
    manufacturing, and use of medical devices understand the governing
    regulations. Participants will be introduced to the regulatory
    process in the international market as well. Often biomedical
    engineering curriculums do not include exposure to these critical
    areas. Therefore, adding this course to students' curriculum will
    give them a competitive advantage. The agenda is structured to
    educate biomedical engineering students and to provide basic and
    refresher training to industry participants.

    An intense, 40 hour, educational program will be led by instructors
    drawn from the requisite industries, legal practitioners and
    government regulators. Diversity within the faculty and participants
    will allow this complex subject to be viewed and understood from the
    "real-world" government, industry and legal perspectives. Broadly
    defined, the course will include the history and dynamics of the
    regulations, government and compliance enforcement structure,
    compliance policies and practices, case studies, round table
    discussions and extensive interaction with the faculty. Participants
    will receive a library of regulatory reference documents and resource

    Course Leaders and Instructors

    Course Coordinators: Marilyn J. Hofford
    Workforce Development, The Greater Cleveland Growth Association
    Barbara J. Black
    Vice President, Education Services & Development, C L McIntosh


    … Deborah Grelle, Director Of Inspections, Cincinnati District
    … A reviewer from Washington


    … Ray Ursick, Vice President for Regulatory Affairs, STERIS, Inc.
    … Janice Brownlee, Director of Regulatory Affairs, Inovision
    Radiation Measurements
    … Duane Praschan, Manager, Regulatory Affairs, Marconi Medical Systems
    … Janet Minnis Webb, President, MedVantage
    … Timothy R. Wells, President, Wells & Associates
    … Nancy Teague, C L McIntosh


    … John E. Jevicky, Attorney, Dinsmore & Shohl
    … Bradley Merrill Thompson, Attorney, Baker & Daniels

    Teaching Materials
    As part of the registration, participants will receive extensive
    documentation of regulatory practices and procedures, including
    publications of FDA and Trade/Professional Organizations, as well as
    copies of visuals used in lectures.

    Course Grading:
    A certificate will be awarded upon completion of the course.
    Attendance for the entire five days of the course is required. Case
    study and simulation teams will be formed, with assigned roles for
    regulatory compliance, legal matters, design research, and production
    engineering. All teams will be given the task of implementing a plan
    to bring a product to market. Academic credit is also available
    through CWRU.

    The Cost

    Cost of the course is $1,400 for participants from industry and $975
    for attendees from government, the non-profit sector, and students.
    Fees include parking, materials, continental breakfast, lunch, and
    snack each day.


    Out-of-town attendees will need to make their own arrangements.
    Nearby hotels include:
    … Glidden House
    1901 Ford Dr.
    Cleveland, OH 44106

    … Intercontinental Suites Hotel
    8840 Euclid Ave.
    Cleveland, OH 44106

    A list of other nearby hotel accommodations is posted on the course

    Course Outline

    Daily Meeting Schedule 8:30 a.m. to 5:00 p.m.

    Day I (Jan. 8. 2001)

    Welcome, Introduction and Course Overview
    FDA amd Medical Device Regulations

    … Organizational Structure - Governance & Authority
    … Legislative History
    … Compliance Enforcement

    Day II (Jan. 9, 2001)

    Clinical Investigations of Medical Devices

    … Developing a Clinical Study Design Strategy
    … Overview of Regulations
    … Adequacy of Investigational Plan
    … Investigational Device Exemptions (IDEs)
    … IDE Guidance
    … Bioresearch Monitoring

    Day III (Jan. 10, 2001)

    Evaluation of Clinical Data
    … Analysis of Results: Study Outcomes and Labeling Claims

    Regulatory Approvals

    … Premarket Notifications (510{k})
    … Premarket Approvals (PMA)
    … Managing the Submission and Approval Process

    Day IV (Jan. 11, 2001)

    Quality System Regulations (QSR): Development, Clinical and
    Manufacturing Considerations
    … History and Introduction
    … QSR Requirements
    … Current FDA Focus: Quality Systems Inspection Techniques (QSIT)

    Day V (Jan. 12, 2001)

    Exporting and Importing Medical Devices
    Post Approval Considerations
    Overview of International Regulatory Processes for Medical Devices
    Sources of Regulatory Information
    Putting it All Together: Case Study

    Discussion - Question & Answer
    Registration Form
    Introduction to Medical Device Regulations

    Monday - Friday, 8:30 - 5:00 p.m.
    January 8-12, 2001
    Dively Executive Education Center
    11240 Bellflower Road
    Case Western Reserve University
    Cleveland, Ohio

    How to register

    Complete this form and mail to:
    Mia Smith
    Edison BioTechnology Center, Inc.
    11000 Cedar Ave., Suite 300
    Cleveland, OH 44106

    or Fax completed form to:
    Mia Smith (216-229-7323)

    Fee Schedule

    Fees are fully comprehensive & include parking, continental breakfast
    and lunch, snacks, and all course materials.

    ___ Industry $1,400

    ___ Students/Government/Non-Profit $975

    Names of Attendees

    Name__________________________ Title_____________________

    Name__________________________ Title_____________________

    Name__________________________ Title_____________________

    Name__________________________ Title_____________________

    Required Information

    Firm or Organization Name _________________________


    City/State/Zip _______________________

    Telephone ____________________________

    Fax ______________________________

    Email address ___________________________

    Method of Payment (Payment must accompany registration)

    ___ Check payable to Edison BioTechnology Center, Inc.

    ___ Charge to credit card: ___ AE ___ MC ___ Visa
    Expiration date: _______________

    Card Number: __________________________________________________ _______________

    Signature: __________________________________________________ __________________

    Registration due no later than December 22, 2000. Cancellations made
    up to December 22 will be refunded at 50 percent. Cancellations
    received after December 22 will not be refunded.

    For more information:
    Visit the conference website at

    Call Denise Richardson (216-229-0400) or Marilyn Hofford
    (216-592-2266) if you have questions.

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