“Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices.”
-EU MDR

As May 2020 quickly approaches, the EU MDR post-market surveillance (PMS) phase of the total product lifecycle is changing. And we understand that global medical device manufacturers like yours are working to fully understand the impact to your organization, as well as what actions and resources are critical to ensure the safety and efficacy of your products - from product release to retirement.

Device Talks – West will take place in Santa Clara on December 9-10, 2019. Amplexor, together with Regulatory Compliance Associates® Inc. (RCA) will be hosting a roundtable breakfast discussion, also known as a ‘Table Talk’, on 10 December at the Santa Clara Convention Center.

RCA will present key insights and best practices relating to implementing a compliant EU MDR PMS platform and identify how to maneuver against potential challenges that may be encountered.

By attending the Santa Clara Table Talk roundtable discussion, participants will learn:

  • The new requirements to establish and create a PMS system
  • What information should be gathered, recorded, translated, (localized) analyzed
  • How to navigate through the new clinical evaluation requirements
  • Actionable steps required to achieve and maintain compliance, while ensuring safety and efficacy

Agenda

7 am Registration and Networking
7:30 am Breakfast
7:45 am Presentation and Roundtable Discussion

  • Dan Schneider, Director – Amplexor
  • Guest Speaker: Stephen L. Coulter, Ph.D., General Manager- RCA

8:30 am Q&A

8:45 am Closing Remarks

Location

Device Talks - West

Santa Clara Convention Center

Santa Clara, CA, US

7 am-8:45 am

Amplexor Table Talks are a unique opportunity for industry peers to come together and gain insights into the various challenges faced within the industry today. We offer an open forum and exchange opinions and views in an informal setting.

About the Speaker

Stephen L. Coulter, Ph.D

Stephen is a General Manager for Regulatory Compliance Associates.  His areas of expertise include quality and regulatory compliance, remediation projects, product development and quality systems audits/audit preparation.  Stephen has 38 years in the global healthcare products industry including medical devices, combination products, diagnostic devices, pharmaceuticals, natural products and personal care products.  The companies at which he has spent his career include Baxter Healthcare and Church & Dwight as well as small start-up companies.  Stephen’s broad technical background is due to the diverse roles that he has fulfilled in his career and dual PhD’s in the fields of Organic Chemistry as well as Polymer Science & Engineering.

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