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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