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Graduate Certificate in Quality of Medical Devices

If you are employed in the medical devices industry, CBU’s Graduate Certificate in Quality of Medical Devices will help you expand your knowledge so you can improve your job performance and take advantage of opportunities for advancement.

What You’ll Study

The certificate program requires completion of three courses. Course work focuses on quality assurance, healthcare packaging, regulatory issues, and quality systems.

Course requirements can be completed online, on campus (usually between 5:30 and 8:14 p.m. for 15 weeks), or a combination of the two. All classes are captured on our media servers. If you cannot make it to a particular live lecture because of work or family obligations, you can watch a video recording later.
All classes can be applied toward the MSCIS program upon successful completion.

Required Courses

You may choose three courses from the following:

ENGM 605. Quality Assurance – 3 credits
Statistical quality control methods for products and services; design of quality control systems; control of quality control inputs. Lecture and problem solving.

ENGM 643. Healthcare Packaging – 3 credits
Introduction to the basics of materials used for healthcare packaging including materials selection. The step for packaging design and development and use of suitable conversion process from raw materials to packages. The considerations used for aseptic packaging and added sterilization process, in needed. Storage and distribution of final products to customers with codes imprinted on products for quick identification of source details. Steps of scope, planning, preparation, and receiving of FDA validation.

ENGM 650. Regulatory Affairs and Quality Systems – 3 credits
Develop a basic understanding of regulatory affairs and quality systems related to medical devices to provide a better cross-functional working relationship and process efficiency.

ENGM 652. Quality Systems for the Medical Device Industry – 3 credits
Develop a basic understanding of quality system requirements for medical device manufacturers based on both FDA and ISO standards.

How to Apply

To apply, submit the following:

  • Completed application with the $75 application fee
  • One official transcript of previous academic credits from each of the colleges or universities previously attended
  • Two letters of recommendation from former teachers or immediate supervisors qualified to attest to your preparation and ability to perform graduate study
  • Current resume
  • Personal statement describing the fit between career objectives and a master’s certificate
  • For international Sstudents only: 
    • A minimum proficiency in English equivalent to an IELTS score of 5.5 or higher, TOEFL iBT internet-based test score between 68 and 76
    • World Education Services (WES) Comprehensive Course-by-Course Report (This evaluation is required for those whose highest degree is from a foreign university.)

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