Saint Cloud State University - 2nd largest University in MN *Three STEM Graduate Education Programs - Regulatory, Quality, and Clinical Research *Academic Internships offered in these Full Time Programs *The course content - practical and delivered by faculty that are experienced full time professionals

1. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
St. Cloud State University
Graduate Education in
Medical Technology
Information Session
International Applicants
Wednesday, April 26, 2016

2. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Agenda
• Introductions
• Directors welcome
• Attendees
• MedTech (STEM) Graduate Programs Overview
• Degree Application Process
• Career Connection

3. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Master of Science
In Regulatory
Affairs & Services
Master of Science
In Applied Clinical
Research
Master of Science
In Medical
Technology
Quality
College of Science & Engineering
Graduate Education in Medical Technology
Director:
Cathy Krier
Director:
Mark Swanson
Director:
Patty Feulner
Started in:
2007 2010 2012

4. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Primary Focus on Medical Devices
Expert Faculty
Industry Professionals in Regulatory Affairs,
Clinical Research, Quality, Engineering,
Biostatistics, & Reimbursement
MedTech Graduate Education Programs
Designed for the Medtech Industry,
working professionals, and those looking
to enter these careers

5. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
St. Cloud State University (SCSU)
• 2nd largest University in MN (>16,000 students).
• SCSU charter includes focus on applied education to
support Minnesota companies that operate globally.
• SCSU Twin Cities Graduate Center (TCGC) STEM
Programs
• ~ 48 TCGC international students on OPT
• MEM w MTQ Electives
• MSRAS
• MSACR

6. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
• SCSU MedTech Industry Advisory Board:
- Made up of top industry leaders in Regulatory, Clinical and Quality
- Identified critical education needs for the medical device industry
- Reviewed & provided vital feedback on program designs
- Global Companies Represented:
- 3M -Medtronic -American Medical Systems
- Boston Scientific -St Jude Medical -Smiths Medical
• Instructors:
- Leading industry subject matter experts in these fields
- Identified key content areas with multiple perspectives
- Developed the needed courses, curriculum and delivery
MedTech Program Industry Engagement

7. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Graduate Objective: Develop deep and broad functional
expertise in medical device clinical research
Program Focus:
• Comprehensive knowledge of clinical trial operations
• Clinical trial design & strategy
• Medical product regulations & ethics in medical research
• Evidence-based medicine, research methods, & biostatistics
• Quality Systems & risk management
• Clinical science and medical devices
• Medical product development life cycle
• Leadership & the role of the clinical research professional
Master of Science in
Applied Clinical Research

8. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Graduate Objective: To become an expert in medical device
Quality and Quality Systems
Program Focus:
• Comprehensive understanding of medical product quality
• Regulatory impact
• Quality Engineering tools & skills (Risk management & use
of statistical methods)
• Quality systems development & implementation
• Product design control, verification, and validation
• Manufacturing process development & validation
• Process control
• Supplier management
• Etc.
Master of Science in
Medical Technology Quality

9. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Graduate Objective: To develop expertise in medical
device Regulatory Affairs for US and International markets.
Program Focus:
• Comprehensive knowledge of FDA & FDA requirements
• Working knowledge of International regulatory agencies &
requirements
• Regulatory strategies
• Clinical trial design and conduct
• Regulatory submissions: clinical, marketing, post-approval
• Compliance with post- approval requirements
• US reimbursement process
Master of Science in
Regulatory Affairs and Services

10. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Three Credential Pathways
• GRADUATE CERTIFICATES (17-18 credits)
• MS Part Time with CULMINATING PROJECT (33-34 cr)
*Meets the fulltime requirement for international
students with F1 or H4 dependent US Visas
• MS Full Time with INTERNSHIP* (36-38 cr)

11. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERINGST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
• International graduate students study in the US. A student visa
requires 8 credits per semester in Fall and Spring.
• Classes held in Maple Grove, Minnesota close to companies
that will hire students for academic internships in their 2nd year.
• Class Details (several students are working professionals)
o Weekday evenings from 5:00 – 9:00 pm CT (17:00-21:00 CT)
o Saturday mornings from 9:00 am – 1:00 pm CT (09:00-13:00 CT)
For detailed schedules go to www.msmtq.com, www.msras.com, or
www.msacr.com
MedTech Graduate Education Programs

12. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERINGST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
o Fall Term: September (Programs begin) - November
o Spring term: January-April
o Summer term: May-June
o Credits correlate to class session hours
• 2 Credit courses have 6 x 4-hour sessions (24 hours)
• 3 Credit courses have 9 x 4 hour sessions (36 hours)
• 4 Credit courses have 12 x 4 hour sessions (48 hours)
o Most courses are 3 credits
MedTech Graduate Education Programs

13. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
MedTech Graduate Education Programs
ACR MTQ RAS
MS Degree (FT)*
Credits:
38 36-38 36-39
Elective Credits: 2-6 1-3 6 - 8
Internship Credits: 4 - 5 4 - 5 4 - 5
*Meets the fulltime requirement for international students with F1
or H4 dependent US Visas

14. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERINGST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Acceptance Criteria
• BS in science, engineering, math or health care
• Undergraduate GPA: >2.75 (4.0 scale)
• Three to five years of business experience preferred
• GRE not required for admission
• Minimum IELTS 6.5 or TOEFL 79 (90+ preferred)
• http://www.stcloudstate.edu/gradadmissions/applicati
on/english-proficiency.aspx

15. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
International Degree Application:
Application Deadlines (for Fall 2016):
• Start your application by May 15th
• Plan two weeks for your course by course transcript evaluation.
• All application deliverables due by June 15th
Application Deliverables:
• Online application form including statement of intent
• English Proficiency Test Results
• 3 letters of recommendations
• SCSU online application; automates collection via email
• College transcript(s) – NACES transcript evaluation
• 1st Year financial solvency (for F-1 Visa) Must be
Course-by-Course

16. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Degree Application Process:
See Graduate Studies:
http://www.stcloudstate.edu/gradadmissions/applicati
on/default.aspx
International Studies
http://www.stcloudstate.edu/internationaladmissions/applic
ation/default.aspx
STEM Program Details
http://www.stcloudstate.edu/internationaladmissions/applic
ation/default.aspx

17. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Career Connection
• MedTech Career Network
– Meet international students across programs
– Attend an Annual Resume Workshop
– Enjoy a professional environment with peers
• Annual MedTech Career Fair
– 15 to 20 Companies
– Exclusively for SCSU students

18. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Common Questions
• What does it cost?
– $780 per credit; 36 credits; ~28k (US dollars)
• What is the duration to complete the MS?
– 2 years
• What is the format? Ie practical modules or
in-site training for more experience?
– 1st year is practical project based coursework
– 2nd year is a blend of coursework and paid
CPT via our academic internship credits.

19. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Common Questions
What are the US employment opportunities?
– Many of our grads are working for 3M, Boston
Scientific, Medtronic, St Jude Medical
– 30+ companies have hired our graduates
– Academic Internships – they can lead to
longer term employment opportunities.
• US Employment: CPT spans 1 year; as a STEM
program there is an extended 17 months of OPT.
Do all MedTech graduates work in the US?
– No; the employment opportunities are global

20. ST. CLOUD STATE UNIVERSITY, COLLEGE OF SCIENCE and ENGINEERING
Cathy Krier, Director of RAS Program
Email: ckrier@stcloudstate.edu
Patty Feulner, Associate Director of ACR Program
Email: pefeulner@stcloudstate.edu
Mark Swanson, Associate Director of MTQ Program
Email: maswanson@stcloudstate.edu
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