BME59500 - Regulatory Compliance for Biomedical Devices

Summer 2017

Days/Time: Arranged / Arranged
Credit Hours: 3

Learning Objective:
The course employs the learning strategies of reading, writing and discussing. A student who successfully fulfills the course requirements will have demonstrated a functional understanding of regulatory compliance for biomedical devices.

Description:
Medical devices are developed and manufacture in a highly regulated environment. This course will provide an introduction, overview, and systematic study of the intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices. Focus is on understanding the critical elements of regulatory science and quality compliance from a Design Control perspective. Instruction and mentoring in regulatory science skills is provided by academics and industry representatives with expertise in their fields. This course is part of a three course series.

Topics Covered:
History of regulation and overview of regulatory affairs; regulatory agencies and oversight; regulatory differences between devices, drugs, biologics, and combination products; current US and EU device regulations and device standards for quality control, quality assurance, and regulatory compliance; purpose and preparation of major documents in regulatory affairs.

Prerequisites:
Graduate standing.

Homework:
Pre-recorded video lectures will be available for viewing. Each week you will be responsible for viewing two lectures, posting reflections, and taking a quiz.

Projects:
Paper (40% of grade). The format for the paper will be described in the first lecture. The paper will cover 3 parts: 1. A written project plan for how to construct a compliant Design Control process that will be flexible enough to accommodate any type of medical device, and 2. Explain how will that process be optimized for a specific type of medical device, and 3.Will include an explanation of how each element of 21 CFR 820 has been considered and integrated.

Exams:
None. Quizzes taken online

Textbooks:
Official textbook information is now listed in the Schedule of Classes. NOTE: Textbook information is subject to be changed at any time at the discretion of the faculty member. If you have questions or concerns please contact the academic department.
Tentative: "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices" by A. Daniel and E. Kimmelman, Second Edition. ASQC Quality Press Milwaukee, WI. Additional class reading documents to be provided via Blackboard Learn.

Computer Requirements:
ProEd Minimum Computer Requirements

ProEd Minimum Requirements: view

Tuition & Fees: view

INSTRUCTOR

Andrew O. Brightman
Phone
765-496-3537
Email
aob@purdue.edu
Office
Purdue University
Martin C. Jischke Hall
206 S Martin Jischke Dr
West Lafayette, IN 47907-2032
Fax
765-494-1193
Instructor HomePage

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