ETLS 722 Medical Device Quality Systems

Instructor:

Kristy Simmons

Time / Location:

Section 09
Wednesday evening, 5:30pm-8:30pm
St. Paul, Binz LL02

Required Text:

• Code of Federal Regulations, Title 21, parts 800-1299.
• ISO 13485: 2003, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.

Optional Text:

None

Supplementary Materials:

Notes will be handed out at the beginning of each class

Course Description:

This class will focus on the quality system requirements, from a regulatory viewpoint, for medical device manufacturers.  The majority of the class time will be spent reviewing the FDA Quality System Regulation as well as ISO 13485 in relation to the ISO 9000 Series requirements.  There will be general discussion on the U.S and European submission process, especially in context of changes related to the quality systems that have been implemented.  A few classes will focus on FDA inspections, and the ramifications of non-conformance.   Classroom methodology will be lectures with substantial student interaction encouraged.  Students will be encouraged to share their experiences from their own companies regarding the subjects being discussed.  Some portions of several of the classes will be presented by students, sharing what they have learned from small group interaction during class time.

Prerequisites:

None

Course Objectives:

To gain an understanding of:

1. the intent and requirements of Medical Device Regulations that affect the design, manufacturing and marketing of medical devices.

2. the impact of not conforming to the regulations.

Learning Outcomes:

1. Develop an understanding of US and European regulations governing the development, manufacturing and marketing of medical devices. (MS-3, MS-8)
2. Develop a basic understanding of new product approval applications and how they are impacted by quality systems. (MS-2, MS-7)
3. Develop a practical understanding of how to develop and manufacture medical devices in conformance with applicable regulations. (MS-1, MS-3, MS-7, MS-9)

Course Methodology:

Lectures, class participation (including and group presentation), paper(s), mid-term project, exam.

Major Assignments:

1. Mid-term project: group paper and presentation.
2. Individual paper
3. Small group project: paper and presentation.
4. Final exam

Grading Policy:

Class Participation

Mid-term Project
Small Group Project
Individual Paper
Final Exam

A = 90% to100%
B = 75% to 90%
C = 60% to 75%

10%

15%
15%
20%
40%

Academic Integrity:

All students are expected to understand and follow the University of St Thomas policies on Academic Integrity. These are described at:
www.stthomas.edu/engineering/graduate/policies

Exams:

Exams are one of the instruments used to evaluate the knowledge gained by an individual student of the class subject matter, and the progress towards meeting the outcomes of the class and the degree.  To this end all exams (in class or take home) are intended to represent the effort of the individual and not a group effort unless specifically stated otherwise.

Students with Disabilities

Qualified students with documented disabilities who may need classroom accommodations should make an appointment with the Enhancement Program – Disability Services office during the first two weeks of the semester.  Appointments can be made by calling 651-962-6315 or in person in O’Shaughnessy Educational Center, room 119.

Attendance
Policy:

Students are expected to attend all class sessions. Circumstances which prevent attendance will be honored up to two instances. Absences in excess of two times may result in a lower grade for the course. Contact the instructor when a special situation arises. All absences require that the instructor be informed in advance.

Instructor Biography:

Kristy Simmons is a Regulatory Affairs Manager in the Cardiac Rhythm Disease Management Group at Medtronic, Inc.  She leads a regulatory staff in the development and implementation of regulatory strategies, processes, and submissions to ensure regulatory compliance and timely global commercialization of products.

Ms. Simmons is proficient in all U.S. submission types; this includes Original PMA, PMA-S, 510(k), IDE, postmarket surveillance, and post-approval submissions.  Ms. Simmons also has experience with combination products and pharma GMPs.  She has international regulatory expertise in the European Union, Japan, Canada, and Australia.  

Prior to joining Medtronic, Ms. Simmons was Medical Device Sales Representative and was a Regulatory Specialist with specific responsibilities in Quality Systems. 

Ms. Simmons has a B.S. in Biology from Saint Norbert College and a M.S. in Manufacturing Systems from the University of Saint Thomas.  She is a member of the Regulatory Affairs Professional Society (RAPS) and has obtained the Regulatory Affairs Certification (RAC).