Regulatory-as-a-Service: Innovative Bundling to Address Compliance Challenges

 

“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 the volume of required translations is increasing. 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. 

Amplexor’s guest speaker, RCA’s General Manager, Stephen L. Coulter, Ph.D., will present key insights and best practices relating to implementing a compliant EU MDR PMS platform and identify how to maneuver against new challenges related to translations and potential challenges that may be encountered.

Webinar attendees will learn:

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

About the Presenter

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.

Session A

27 February - 5:00 a.m. MST



 

Session B

27 February - 11:00 a.m. MST