Regulatory Aspects of Medical Product Development

Catalog description

The regulatory pathway for a company to commercialize and sustain new products or services can significantly impact executive decision making process. This course examines the aspects of FDA and European regulations on a company's decision process to develop and commercialize products. The course exposes students to various aspects of regulation, specifically focusing on medical devices and in vitro diagnostics companies. Regulatory strategies for commercialization are developed based on the intended market, geographic location, stage of a company (startup to mature), and funding of the project. In addition, regulatory impact of FDA oversight and European Union oversight via Notified Bodies is explored. Development of a regulatory strategy, product submittal concept model and compliance model per FDA and European regulatory requirements including costs of implementation will be required for course completion. FDA, ISO 13485, ISO 14971, Good Laboratory Practice (GLP) and Clinical Laboratory Improvement Amendments (CLIA) compliant quality system are examined.