The Regulatory Environment of Medical Devices and Implants
The University at Buffalo Division of Continuing and Professional Studies
Is pleased to announce our newest certfiicate program...
THE REGULATORY ENVIRONMENT OF MEDICAL DEVICES AND IMPLANTS CERTIFICATE PROGRAM
Identifying the need...
Biotechnology, biomedical and Life Sciences are on a fast track to become one of the leading industries for economic growth in the Buffalo-Niagara region, across the nation and around the world.
Our response to industry and workforce needs...
As new technologies emerge and the biomedical and life sciences industries develop, incumbent workers and those individuals preparing to enter the biotechnology workforce need knowledge of the regulatory environment in which life sciences products, medical devices and implants are developed, manufactured and sold. Strengthening this knowledge base among life science industry workers is the basis for the new certificate program, "Regulatory Environment of Medical Devices and Implants" (REMeDI).
About the REMeDI CertificateProgram
The objectives of the Regulatory Environment Of Medical Devices and Implants (REMeDI) certificate program is to provide an expanded Life Sciences work force with knowledge and skills needed to enter or move up in the biomedical products industry.
Who should enroll in REMeDI
Scientists, researchers, legal and regulatory professionals, marketing and sales teams, design and packaging experts, writers, and manufacturing teams will find the REMeDI training enables them to make valuable contributions to the success of their companies. Individuals who are interested in beginning a career in the Medical Products industry will also benefit greatly from this targeted program.
Academic credit or noncredit
MFC courses are offered for University academic credit and may be applied as electives to meet degree requirements. Certificates will be awarded to students who complete all required courses with a combined grade average of "C" or better. The Regulatory Environment of Medical Devices and Implants REMeDI courses are also available as noncredit courses to those individuals not interested in earning academic credit but wish to earn a Certificate of Completion from the University at Buffalo. Noncredit courses are designated with the course prefix of BLS. All students enrolled for academic credit are bound by the policies and regulations of the University at Buffalo.
Students registering for courses will declare their intent to earn academic credit or register as noncredit students in the registration process. Students registered for noncredit courses may not apply for academic credit at anytime. Students enrolled for academic credit may not change their enrollment status to noncredit at any time.
Registration procedures and schedule of classes
Credit: (MFC courses) For class schedule and more information... click here . If you have any questions about taking these courses for ccredit, please call our office at (716) 829-3131.
Noncredit: (BLS courses) Registration and payment...Go to the following link and select your choices of courses in biomedical and life sciences. Please have your credit card available to complete the registration process on-line. We accept the following credit cards:
Tuition, fees and refund policies
Credit: All students registering for academic credit will pay the current UB tuition rate of $207 per credit hour + fees. Fees will vary depending on your enrollment status with UB. New students enrolled in ONLY MFC courses will pay the MFC student fees (part-time or full-time) as listed on the following page (click here). All students are bound by UB policies and regulations as described at the following website (click here). Students registering for MFC credit courses will be billed rather than having to pay at the time of registration.
Noncredit: Course fees are listed with each course found in noncredit course schedule. Students registered for noncredit courses may receive a full refund if our office is notified in writing prior to the first day of class. Noncredit course fees will not be refunded starting with the first day of class.
Certficiate Program Requirements
The REMeDI Certificate program consists four core courses (MFC 250, 254, 258 and 448) that are required to complete certificate requirements. MFC courses are offered for university academic credit and may be applied as electives to meet degree requiements. Certifiates will be awarded to students who complete all four courses with a combined grade average of "C" or better.These courses are also available as noncredit courses to those individuals not interested in earning academic credit but wish to earn a Certiifcate of Completion from the University at Buffalo.
BLS 250/ MFC 250 INTRODUCTION TO HEALTHCARE IN THE U.S. (3 cr.)
Introduction to the structure and process of healthcare in the United States, as well as critical policy issues the system confronts. Topics include the historical development of the healthcare system; types of facilities, services, agencies, and personnel that constitute the system; levels of health-service intervention and special problems of high-risk populations, and responses to each by the healthcare system; quality-control activities; and critical health-policy dilemmas that healthcare administrators face. (With permission of the REMeDI Academic Director, students with 2+ years in the healthcare industry may waive MFC 250, but will be required to substitute a REMeDI capstone course to meet certificate requirements).
BLS 354 / MFC 354 REGULATION IN THE HEALTHCARE ENVIRONMENT (3 cr.)
The New York State healthcare industry is one of the most regulated employers in the United States. Regulations permeate and control the entire system: hospitals; long-term care facilities; home health agencies; physicians, nurses and caregivers; insurance companies; ambulatory care facilities; and others. How a provider or facility functions and what services can be provided are determined by regulation or through the regulatory processes presented from the perspective of both the Department of Health and the specific providers.
BLS 358 / MFC 358 INTRODUCTION TO MEDICAL DEVICES AND IMPLANTS (3 cr.)
This course is designed for students who have an interest in the healthcare field, in order to prepare for or accelerate a career in healthcare and/or the medical products industry (devices, drugs, diagnostics). You will learn the principles of materials science (chemistry, physics, mechanical engineering) as they relate to material interactions with cells, tissues, and organs (biology, physiology, biophysics).
BLS 448 / MFC 448 REGULATORY ASPECTS OF MEDICAL DEVICES (3 cr.)
This course is designed for students who plan to develop a career in the life sciences products industry. The course will cover U.S. and international regulatory requirements for medical devices and drugs, as applied to bench research, animal testing, clinical testing, manufacturing, sterilization, and post-market surveillance. Our purpose is to present key regulatory concepts and practical applications that will enable you to understand the historical context of medical product regulations and to have a working knowledge of the current requirements placed on product development, manufacturing, and use in the U.S. and other major markets in the world.
REMeDI Capstone Courses
The certificate program concludes with a choice of a capstone course, either "Biomaterials Science of Cell/Surface Phenomena" or "Evaluation of Biomedical Materials."
BLS 501 / BMA 501 BIOMATERIALS SCIENCE OF CELL/SURFACE PHENOMENA (3 CR.)
The main objective of this course is to refine and build upon your prior knowledge of the basic properties of fabricated plastics (polymers), metals, ceramics, and natural substances, by adding a detailed understanding of interactions between living and nonliving materials, and their consequences for public and environmental health. Topics include proteins at interfaces, biofilms, cell-cell interactions, biomaterial-centered infections, osseointegration, cell membrane models, and cancer cell-cell interactions.
BLS 520 / BMA 520 EVALUATION OF BIOMEDICAL MATERIALS (3 CR.)
This course serves a multidisciplinary group of students, assuming a starting level of Bachelor's degree knowledge. From that point, we address (1) characteristics of specific materials used for various types of devices; (2) selection criteria based on function and longevity; (3) performance testing in vitro and in vivo; (4) evaluation of material breakdown in biological media, and potential toxicologic consequences; (5) design of clinical trials; (6) surgical considerations; and (7) ethical, regulatory, and legal issues. The course utilizes your primary field of expertise as guide to specific topics of biomaterials evaluation. A "case study" midway through the course allows you to work together to actually design and promote a new implant device for an unmet medical need, with particular attention to regulatory requirements and market realities. You are encouraged to share your own expertise with the faculty and your colleagues in the class.
The REMeDI certificate program courses will be taught by experts recognized by the American Institute for Medical and Biological Engineering as leaders in the field, and who have long-standing research and development relationships with industry.
The academic director of the program is Anne E. Meyer, Ph.D., research associate professor in the Department of Oral Diagnostic Sciences, School of Dental Medicine, and director of the UB site of the National Science Foundation-designated Industry/University Center for Biosurfaces.
Additional Information and Questions:
For Additional Information or questions about the REMeDI Certificate Program, please contact:
The State University of New York at Buffalo
Division of Continuing and Professional Studies
Millard Fillmore College
3435 Main Street, 128 Parker Hall
Buffalo, New York 14214-3007
Telephone: (716) 829-3131
Fax: (716) 829-2475