Master of Science in Medical Device Quality Management (MDQM)

Overview

The OrthoWorx Center of Excellence at Grace College presents the Master of Science Degree Program in Medical Device Quality Management (MDQM).

You know who you are – you love learning and you’re serious about advancing your career in the world of Medical Device Manufacturing. Grace College is adjacent to Warsaw, Indiana – the Orthopaedic Capital of the World® – and is proud to partner with OrthoWorx to offer this accelerated, industry-focused graduate program. You will learn alongside industry colleagues and from industry professionals who bring not only academic excellence to the classroom, but also their real-world experience.

The Orthopaedic/Medical Device manufacturing environment is dynamic and the stakes are high. There is no room for error when patient safety and your company’s reputation are on the line. Effective quality systems and practices must be in place and followed every day for maximum productivity and device effectiveness. Medical device professionals trained in quality management ensure excellence in all critical processes including design, manufacturing, record keeping, complaint handling, auditing and testing, employee and vendor relations.

The MDQM Master's Program consists of twelve courses offered in a convenient one-night-a week or weekend format at Grace College. All courses are either four or five weeks long and combine outstanding lectures, activities, and online resources. Distance learning is also available through lecture capture and video conferencing technology. The in-depth curriculum is built around materials endorsed by industry bodies such as the Food and Drug Law Institute (FDLI), the Food and Drug Administration (FDA), The Regulatory Affairs Professional Society (RAPS), and the American Society for Quality (ASQ).

Please contact the program director to discuss your background, educational goals, and the MDQM Master's Program in depth.

This may just be the program you have been looking for to turn your love of learning into career advancement! A cohort is forming now to begin the program next May so don’t delay. Click on the link below to complete an online application.

Do you have your master's degree but want to become a better equipped Quality Professional? If so, click here to learn more about the MDQM Certificate Program.

To discuss your educational goals and the MDQM Program further, please contact the program director:
Allyn Decker
deckerap@grace.edu
574-372-5100, ext. 6509 or 855-267-6722

Courses

Quality Systems (QMD 5000)

Content areas in this course will include:

  • Quality concepts
  • Management responsibility
  • Quality policy
  • The cost of quality
  • Survey of the regulations; FDA QSR, global regulations, pre-market submissions, 510(k), PMA, CE mark, medical device law
  • Review of all quality system elements (quality system requirements; design controls; document controls; purchasing controls; identification and traceability; production and process controls; acceptance activities; non-conforming product; CAPA; labeling and packaging controls; handling, storage, distribution, installation, and records; servicing; and statistical techniques)
  • Quality systems interactions and interdependencies (integrated quality management), implementation, and compliance with FDA QSR (CFR21 part 820), ISO, and other regulatory and notified body regulations
  • Audit; QSIT, supplier audit, internal audit, program and schedule development, audit readiness, audit process management, addressing audit findings, audit reports, audit questions
  • Managing regulatory compliance inspections/audits (FDA, notified bodies, etc.)
  • Document controls; document control ANSI/AAMI/ISO standards and compliance, records management (records retention, device master record, device history record, quality system records), complaint files, training requirements

Proposed 2014 Dates: Jan. 6, 13, 20, 27, Feb. 3

Survey in Statistics (QMD 5400)

Content areas in this course will include:

  • Probability and statistics
  • Data analysis
  • Statistical process control
  • Statistical tools for six sigma; charts, controls, and diagrams
  • Design of experiments; establishing, controlling and verifying process capability and product characteristics

Proposed 2014 Dates:  Feb. 10, 17, 24, March 3, 10

Design Control and Assurance (QMD 5200)

Content areas in this course will include:

  • Research and development processes (phase gate, etc..), new product development, design control requirements – FDA and MDD
  • Design inputs and outputs, design review, design transfer and changes, design history files
  • Validation and verification
  • Mistake-proofing, failure modes, and effects analysis for design
  • SWOT analysis
  • Avoidance of overly burdensome processes
  • Human factors and competency requirements 
  • Design for manufacturability and reliability
  • Project planning

Proposed 2014 Dates:  March 17, 24, 31, April 14, 21

Post Market Surveillance (QMD 5100)

Content areas in this course will include:

  • Complaints and complaint handling
  • Reporting to regulatory bodies (FDA, global)
  • MDR reporting
  • Corrections and recalls, developing and deploying an action plan, market withdrawals
  • CAPA – elements of effective CAPA, verification and validation of CAPA, CAPA effectiveness, documenting CAPA
  • Post market clinical data, retrospective analysis, trending and tracking, trending tools, signal detection informing appropriate action, risk assessment
  • Health hazard assessments
  • Adverse event investigations
  • Trend investigations, root cause analysis
  • Proactively surveying of customers (proactive versus reactive), customer loyalty surveillance

Proposed 2014 Dates:  April 28, May 5, 12, 19, (off for Memorial Day) and June 2 

Manufacturing Quality and Supply Chain Management (QMD 5300)

Content areas in this course will include:

  • CGMP (device master record, production and process controls and changes, packaging, labeling, storing, distribution, etc.)
  • Failure modes and effects analysis for process, inspection, verification and validation (for both process and software), metrology, clean and sterile requirements
  • Statistical process control
  • Non-conforming product, identification and traceability of product, environmental control, manufacturing material removal, calibration, acceptance activities
  • Calculating cost of quality, quality programs and initiatives, strategies for cost improvement, relationship between quality improvements and financial performance, lean principles and processes, introduction to six sigma, metrics, performance optimization,
  • Diagnosing and solving problems in real time
  • Supplier selection, supplier quality, supplier controls, raw material quality control, customer supplier partnership management, supplier non-conformances, supplier certification
  • Purchasing controls

Proposed 2014 Dates:  June 9, 16, 23, 30, July 7

 

*NOTE: MDQM Certificate (1000 series) requires all five classes.  A Bachelors in Quality Management (3000 series) requires all classes plus the Bachelor in Management degree core (GOAL curriculum). Bachelor’s students can elect which five GOAL courses will be replaced by QM courses. A Master’s in Quality Management (5000 series) requires all classes (with an additional level of work per class) plus ORCA core and three regulatory courses.   Proposed dates are subject to change.