WELDON SCHOOL OF
BIOMEDICAL ENGINEERING
BME 595: Regulatory Compliance
(3 credits, Summer)
Course Description:
Medical devices are developed and manufactured 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.
Time/Location: M-W-F, 3:30 pm - 5:20 pm, Wang Hall
Dates: Mod 2 & 3 of Purdue Summer Session; June 13 – Aug. 5
Prerequisites: none
Course Coordinators:
Vickie J. Maris, Director, Graduate Programs Director, Weldon School of BME
Contact info: (765) 494-2982, vjmaris@purdue.edu
Perry W. Guinn, Vice President, Quality Assurance and Regulatory Affairs, Cook Biotech
Contact info: (765) 497-3355, guinn@cookbiotech.com
Office Hours: Optional online chat sessions in Blackboard Learn or other digital platforms; office
hours via phone or email by appointment
Required Texts:
"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.
Course Outcomes: A student who successfully fulfills the course requirements will have
demonstrated a functional understanding of regulatory compliance for biomedical devices.
Learning Strategies: The course employs the learning strategies of reading, writing and discussing.
Assessment: Grading is based on online Reflections (24%), online Quizzes (36%) and a Paper (40%).
Reflections posted online (Blackboard Learn):
Posting 1 – due by 11:59 pm EST on Monday - Based on your weekly reading, write a paragraph
reflecting on how does the referenced part of 21 CFR 820 impact Design Control?
Posting 2 – due by 11:59 pm EST on Wednesday - Based on the previous week’s lectures and your
reading, write a paragraph reflection on how does the type of product being made influence this
part of the regulatory compliance process?
Quizzes taken online (Blackboard Learn):
Quizzes covering the reading assignment and previous class presentations will be offered in a 30minute format and access will be granted each week from Friday to Monday.
Paper submitted online:
The format for the paper will be described in the first class session. The paper will cover 3 parts:
1. Written project plan for how to construct a complaint Design Control process
that will be flexible enough to accommodate any type of medical device, and, due by
11:59 pm EST on Monday
2. Section that explains how the process will be optimized for a specific type of medical device,
and,
3. Section that explains how each element of 21 CFR 820 has been considered and integrated.
Caution: This is not about how to construct a compliant Quality Management System, but you
need to know how a compliant QMS works in order to complete the assignment.
Each assignment is worth a point value and total accumulated points will determine the course
grade.
Grading scale:
90-100% A
80-89% B
70-79% C
60-69% D
0-59% F