Why You should Attend:
The 2nd Annual Risk Integration & Quality Management for Medical Devices conference will bring together quality, regulatory affairs, and compliance professionals to benchmark current risk management strategies against other peer organizations, interpret new FDA and European guidance’s, as well as analyze the ISO 13485 and 14971 standards.
Attending this marcus evans conference will enable you to take a more holistic and proactive approach to strategic risk management for medical devices. Within each device lifecycle, all potential risks are accounted for, whether they are biological, environmental, software, user error, labeling, or even a risk due to the complexity of use. In order to be effective, companies must employ continuous risk assessments to establish a baseline and categorization of the amount of risk before being able to implement controls to monitor and mitigate that risk. Attendees will develop a strategy to mitigate risk in all phases of the device lifecycle including: planning, policies, procedures, analysis, evaluations, monitoring and controlling of risk.
Practical Insights From:
Consumer Safety Officer, Cardiovascular Devices Branch, Office of Compliance and Division of Manufacturing and Quality, Center for Devices and Radiological Health
U.S. Food and Drug Administration
Joseph M. Purpura, MD, MS,
Executive Director, Head of Device Safety, Global Patient Safety & Epidemiology
Senior Vice President, Quality & Regulatory Assurance
Nihon Kohden America
Global Vice President, Quality and Compliance
Vice President, Quality Assurance and Regulatory Affairs
Vice President, Quality Assurance