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 641. Distribution and Medical Device Packaging
Physical distribution systems and distribution hazards. Rules and regulations governing distribution packaging and industry guidelines and practices. Basics of packaging materials, forms and sterilization methods used in biomedical industry. Packaging design, development, and validation. Special projects. Three
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 credit