Managing today’s regulatory and compliance expectations while preparing for changes in the future
BSI is proud to bring you the premier event for the medical device community in 2012. Our complimentary, exclusive, one-day roadshow will bring together the medical device community and global industry experts to discuss and engage the audience around the importance of entering today's European market and preparing for the expectations and changes in the future. For the first-time ever, we are bringing global expertise, knowledge, and resources to you.
Please join us in the city nearest you opposite.
The BSI Healthcare Roadshow Agenda*
7:30 – 8:00 am - Continental Breakfast and Registration
8:00 – 8:30 am - Welcome & Opening Remarks
8:30 – 9:45 am - The Importance of the Market, Acceptance of Innovation and Predictability of the Regulatory Process. Understand why the European market is critical to leading North American medical devices manufacturers, the reasoning behind why industry stakeholders believe entrance to Europe is essential, and if the European regulatory system is delivering expected benefits.
9:45 – 10:00 am - Morning Refreshment and Networking Break
10:00 – 11:00 am - Meeting Changing & Increasing Clinical Data RequirementsDiscussion of current EU regulations, upcoming revisions and how these changes will affect clinical data requirements as part of design dossier and technical documentation submission for all device risk classes.
11:00 – 11:45 am - Best Practices in Planning for Reimbursement in EuropeDiscussion of current requirements in Directives, Harmonized Standards and EU Guidance. Discussion will also encompass proactive feedback, complaint handling, clinical follow-up, when registries help and how regularly monitoring data can improve quality, safety controls and maintain full regulatory compliance.
11:45 – 12:45 pm - Networking Luncheon
12:45 – 1:45 pm - Best Practices for Enhanced Post-Market SurveillanceIntroduction to Reimbursement and Health Economics in the medical device industry and discussion of which aspects are critical in early clinical activities.
1:45 – 2:45 pm - Using Technology to Maximize Quality Management System RequirementsUnderstand how a quality management software system helps enable medical device manufacturers achieve speed-to-market, while reducing overall costs, increasing internal efficiency, and effectively managing ISO 13485 and FDA requirements.
2:45 – 3:45 pm - Update on Changes to European Regulations Affecting Medical Device Directives: Setting Future Regulatory ExpectationsUnderstanding upcoming revisions, how they will impact medical device market access, and discuss latest European position and reasoning behind the changes.