Harmonizing QA & RA in MedTech: Epredia’s Journey

Medical Device, Medical Device Safety and Regulation, Medical Device Diagnostics,
  • Thursday, April 15, 2021

With the rapid changes in MedTech, the regulations and quality requirements also need to keep pace and address specific needs across different geographies. To do this, MedTech companies need to focus on connecting quality and regulatory to harmonize the product lifecycle.

Epredia, a global precision cancer diagnostics company, is doing just that. Epredia has consolidated four siloed systems into a single quality platform with a clear path to unify regulatory affairs and quality assurance. This harmonization helps eliminate manual efforts, reduce compliance risk and speed the total product lifecycle.

Register for this webinar to hear experts from Epredia share best practices and lessons learned in their journey to modernize their quality and regulatory systems, including connecting quality documentation, training, a new RIM solution, future connections to CAPA, complaints and change control. Experts from Veeva MedTech will also share industry best practices and trends.


Mark Ramser, Epredia

Mark Ramser, Senior Director - Global Quality, Epredia

Mark is currently the Senior Director, Global Quality at Epredia. He has global responsibility for all quality-related activities. Mark was previously the Senior Global Director of Quality Assurance for the Industrial and Healthcare Materials Group at Avery Dennison. While there, he focused on harmonizing quality management systems globally to be compliant with ISO 13485, Title 21 CFR Part 820, ANVISA (Brazil), KGMP (Korea), Medical Device Single Audit Program (MDSAP) and the Medical Device Regulations (MDR).

Message Presenter
Brian Scogland, Veeva MedTech

Brian Scogland, Director Regulatory Strategy, Veeva MedTech

Brian is a Director of Strategy for Veeva MedTech. He is responsible for ensuring customer success by developing the strategy for adoption of new capabilities of Veeva solutions for both new and existing customers. Brian has more than 20 years of experience in the Life Sciences industry with a focus in Medical Devices and has held roles in both Regulatory Affairs and Quality Assurance. Brian has previously worked at Boston Scientific and most recently as a consultant with Halloran Consulting Group.

Message Presenter

Who Should Attend?

This webinar is targeted at Directors and upwards for the following business areas:

  • Quality
  • Regulatory

What You Will Learn

In this webinar, participants will learn about:

  • Key drivers to connect QA and RA systems
  • Best practices to implement a unified, connected system
  • How a cloud-based solution increases collaboration, control and visibility
  • How to align QA/RA stakeholders to drive end-to-end control

Xtalks Partner

Veeva Systems Inc

Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 975 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.

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