Medical Technology Quality MS

Knowledge of medical device and quality regulatory requirements for both FDA and international regulations and standards

Knowledge of how to build productive relationships with suppliers. Auditing and rating suppliers. Create specifications quality agreements and corrective actions

Knowledge of tools and applications for the design and manufacturing of quality medical devices, including application of predictive statistics for sampling, and how to address multiple variables through design of experiments

Knowledge of risk management in the development and use of medical devices. Standards, regulations, methods, and tools for identifying, analyzing, and controlling risks and hazards

Knowledge of the application, management responsibilities, and planning concepts of Quality management systems. US and international standard requirements, and current document control processes in the development, manufacture and distribution of medical devices.

Knowledge of FDA and ISO design control requirements for medtech product development, translation of user needs into product design, risk management in the design process, and how design reviews and a phased approach assure designs are safe, robust, and effective

Knowledge of design verification, design validation, and clinical studies using FDA Quality System Regulations and ISO 13485 requirements

Knowledge of quality tools to validate that a manufacturing process is well characterized, tested, capable, and controlled to demonstrate compliance and control risks and costs. Using designed experiments. Determining sample size and protocols, report writing, and validation

Knowledge of methodologies to prevent product failures, anticipate potential problems, and correct them

Knowledge of how to maintain process capability and output quality through statistically-based process plans