RCRI provides comprehensive, educational services in the form of on-site training, seminars, and Webinars. From clinical study elements, regulatory and quality systems, health economics, reimbursement, and compliance, RCRI can customize an educational event to meet your specific needs and expectations.
Health Economics: Demonstrating the Value of Medical Technologies
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Regulatory clearance or approval was once the primary challenge of bringing a new or improved medical device to the market. Now a growing number of payers and providers are not only requiring technology innovators to demonstrate clinical value, but also economic value before they consider use of new technology. This presentation discusses how to incorporate value-based strategies important to key stakeholders as part of an overall reimbursement strategy.
IVDR Update – Get Ready for the Ride
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With the May 5, 2017 publication in the EU Official Journal, the IVD Regulation became law. The new regulation, now known as Regulation (EU) 2017/746, includes sweeping changes that will require significant planning and resources.
Writing CERs to Rev. 4: Points to Consider and Gaps to Bridge
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With the June 2016 revision of MEDDEV 2.7/1 to Rev. 4 (Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC), medical device manufacturers were faced with the immediate need to update their CER procedures. Significant changes in the recommended format, working definition of equivalent devices, risk based minimum periods for review, and literature search criteria are some of the areas creating the greatest impact on maintaining compliant CERs and Technical Files. This webinar presented strategies for preparing Rev. 4 compliant CERs.
Reimbursement: Understanding the Key Concepts to Maximize Business Success
Reimbursement is an increasingly-significant challenge in the healthcare environment. Medical technology may receive regulatory approval and be proven clinically effective, and still fail in the marketplace – all due to lack of reimbursement. To ensure success, medical companies need to be familiar with the coverage, coding, and payment landscape for the technology they are selling. In addition, companies need to understand how reimbursement affects existing business opportunities and be familiar with the latest trends in healthcare delivery that could affect them.
Upcoming Changes to the European IVDR:
Meeting New Clinical Evidence Requirements
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The upcoming changes in the European Medical Device Regulations will significantly impact IVDs. The new classification rules for IVDs will result in more premarket reviews of IVD product technical files which may slow down market launch plans. Will you have the clinical evidence needed to declare conformity with the updated essential requirements when the new Europe IVD Regulations (IVDR) go into effect later this year? The requirements apply to new products as well as products already on the market. This Webinar was held on Wednesday, June 29, 2016.