Quality of Medical Devices | CBU

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The Graduate Certificate in Quality of Medical Devices was created to meet the needs of the Medical Device industry. It expands knowledge to improve job performance and increase the opportunities for advancement in the medical device industry.

All course requirements can be completed online, live (usually between 5:30 and 8:15 p.m. for 15 weeks) or a combination of the two. All classes are captured on our media servers so 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 MSEM Program upon successful completion.


Choose three from the list of courses below:

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

ENGM 643. Healthcare Packaging
Introduction  to  the  basics  of  materials  used  for  healthcare  packaging  including  materials  selection.  The  steps  used  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, if needed. Storage and distribution of final products to customers with codes imprinted on products for quick identification of source details. Finally the most important steps of scope, planning, preparation, and for receiving of FDA validation. Three credits

ENGM 650. Regulatory Affairs and Quality Systems
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. Three credits

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

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