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November 2017

Webinar: Preparing Your CER For MDR

November 28 @ 8:00 am - 5:00 pm
Webinar Online Event, OH United States

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. The time to plan and act on these changes is now. The Clinical Evaluation Report (CER) is required under the…

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NAMSA Webinar: ISO 10993 Update: Understanding the Use and Value of Biocompatibility Standards for Medical Devices

November 29 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for this webinar on November 29 from 12 pm - 1 pm. Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan. In today’s world, however, the simplicity of the above process is increasingly questioned given the recent requirements of ISO 10993-1: Biological evaluation…

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December 2017

Webinar: U.S. FDA Advisory Panel Meetings, Strategies to Maximize Success, presented by NAMSA

December 7 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

To better understand how to effectively prepare and plan for successful Advisory Panel meetings, NAMSA is partnering with X-Talks to present the webinar, “U.S. FDA Advisory Panel Meetings: Strategies to Maximize Success”

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