Kristine Curran Mechem runs the California office for the East of England International. She has worked for a British government agency for the last four years that supports Life Science companies with their international expansion plans. In this role, she has helped companies better understand the regulatory process in Europe, the market opportunity and whether to partner or go direct. She has worked with a number of medical device and pharmaceutical companies in assessing European marketing opportunity and guidance on regulatory filings. Kristine has 20 years experience in high tech and life science market planning, corporate planning and business development. She is currently teaching a class at UC Berkeley on Biotech European Business Development. Ms. Mechem has a Ph.D. from the University of Chicago and is an alumni of the Stanford Business School.
This presentation is an introduction to the regulatory process in the European Union. It will discuss the Medical Device Directive and the regulatory process in Europe including what is covered under the directive, which agencies are involved (e.g., EMEA, MHRA, notified bodies), the classification of devices, the CE mark and the quality standards (ISO). Additionally, it will compare and contrast the European regulatory process to the U.S. medical device regulatory process. The focus will be on registration of products but there will be a limited discussion on clinical trials.
Target audience: Companies who are new to the European Regulatory process or employees who are new to the European Regulatory process.
