Design Controls, Risk Management and Clinical Studies for Medical Technology Industry

This module will provide in-depth learning on design control processes in the research phase and application of risk management analysis working towards the fulfillment of a clinical investigation.  A thorough evaluation of the design control methods, testing and validation processes will be explored.  Suitable manufacturing processes and cleanroom validation will be examined by device category.  A thorough review of risk analysis and risk management concepts will be evaluated especially in the context of the medical device life-cycle.

Clinical Studies on medical devices are critical to demonstrate safety & efficacy and mandatory for the manufacturer.  This module will take students through the different types of studies, the relevant research stages and provide a thorough understanding of the key stakeholders and deliverables involved.   The regulatory professional is a key contributor to the clinical study process and must have the ability to engage professionally and competently with Authorities. 

1. Identify and interpret the relevant EU, U.S. regulations, guidance and applicable standards for Device Design, Risk Management and Clinical study phases.

2. Explain and justify the design, testing and manufacturing transfer processes along with the cleanroom validation expectations that impact regulatory inputs in technical files for medical devices.

3. Critique risk analysis in line with regulations and relevant standards including ISO 14971 proportionate to the device classification.   Determine the design review stages and compile the corresponding market applications. 

4. Demonstrate competency in the Clinical evaluation process to ensure that the key regulatory and business deliverables are achieved.