Upon completion of the Translational Life Sciences Concentration, the student will be able to:

• identify risks and design process controls to reduce risk to product quality.
• determine the correct classification of medical devices in order to design an appropriate development strategy.
• identify primary and secondary clinical trial targets to demonstrate product safety and efficacy.
• describe the medical device and pharmaceutical Quality Systems, and how those systems enable organizations to consistently produce products that are of the purported quality and safety, and meet user needs.
• describe what needs to be studied and demonstrated during medical device and drug product development.
• determine effective ways to monitor and predict product process performance.
• demonstrate practical use of risk management tool.