Welcome to MedCon 2010!
The FDA and Xavier University invite you to attend MedCon 2010 - a Global Conference for the Medical Device Industry. Global regulatory officials and industry experts will facilitate not only general session discussions, but also three separate track sessions that are specific to Quality, Regulatory and Clinical Trial issues. At MedCon 2010, you’ll have access to medical device industry trends, development updates and news—all in one place.
- For medical device companies of all sizes
- For employees at all levels
MedCon 2010, the first annual Medical Device Industry Conference, offers a unique focus on the industry’s most critical issues from a global perspective. Come hear what top level FDA, Field Investigations, and industry experts are saying about the issues that affect you.
Featuring panels of Global Regulators, our Plenary Session Agenda will provide updates on Compliance Challenges, the Global Approval Process for Medical Devices, and the Global Harmonization Task Force initiative.
Our Quality Track will cover medical device design controls, process validation (risk management), quality assurance for combination products, post market surveillance (CAPA, Complaints, Corrections/Recalls), device supplier controls, management review and international inspection preparation.
Our Regulatory Track will discuss international filing requirements for medical devices, combination product filings, Impact of design and process changes, 510k filings, MDRs, medical device promotion prior to approval, FDA readiness, FDA updates, and a joint session with our Clinical Track participants.
Our Clinical Track will feature the IDE Process and Pre-IDE meeting preparation, study design, a discussion on clinical research/trial requirements, the integration of a clinical trial system into a quality system, and a joint session with our Regulatory Track participants.
|
