MEDDV 111 - Database Management for Medical Devices

Maximum of 3.0 possible Credits
Covers relational databases, programming languages, life cycles, validation, compliance, security, backup/archive, ethics/privacy, regulations and regulators. Includes database model comparisons, setup of validation procedures, security model, code of ethics. Prerequisite: Concurrent enrollment in or completion of MEDDV 110.

Course-level Learning Objectives (CLOs)
Upon successful completion of the course, students will be able to:

Describe the role of the Database Manger in a medical device manufacturing environment. [COMMUNICATE]
Define relational database and relational database management systems and describe their advantages and disadvantages. [COMMUNICATE]
List alternatives to relational database management systems and describe their advantages and disadvantages. [REASON]
Compare and contrast Extensible Markup Language (XML) and Structured Query Language (SQL). [REASON]
List and describe the components of both product and software lifecycles. [COMMUNICATE]
Define compliance as it relates to data storage and management and list common compliance standards used in medical device manufacturing. [REASON]
Identify and explain each component of security as defined by the Food and Drug Administration (FDA). [COMMUNICATE]
List the different levels of security and give an example of a department and / or position within a medical device manufacturer that would have access at that level. [REASON]
Create a backup and archiving plan. [ACT]
Describe how the Health Insurance Portability and Accountability Act (HIPAA) impacts database management and liability for the IT department. [ACT]