Thank you to our fellow sponsors for conducting the following education sessions:

10:00–10:45 am

Unified Rim: End-To-End Submissions Development—From Planning Through Archival


Companies should be able to plan and complete submissions within a single system—not five, ten, or more. If commitments are unified with submission planning, regulatory affairs can easily track the status of responses. If content plans are unified with document management, regulatory operations can track the progress of expected components. And with unified publishing, a continuous publishing process would reduce cycle times and stress levels during crunch times. See how unified RIM can transform work-streams for HQ, affiliates, and partners.

Marc Gabriel, Sr. Director, Vault RIM
Rachel Belani, Director, Vault RIM

3:00–3:45 pm  

The New Medical Device Regulation in Europe


The biggest single change to the medical device regulations in Europe since CE marking was first introduced back in 1993. This talk from Maetrics will take you through the main changes to the regulations from the old medical device directive and will outline the key requirements affecting manufacturers moving forward into the new era. With no grandfathering of existing products being permitted this new regulation affects all devices being sold into Europe. If you haven't already begun planning your transition, now is the time to act, or you risk missing the boat altogether.

Pete Rose, managing director, Europe, Maetrics

12:15–1:00 pm

Document Management for Compliance in MasterControl


From a DHF to your volumes of product submission documents, the process of collecting all of the content across your organization can be extremely daunting. This session will highlight the pains of managing the registrations of multiple products across multiple markets and demonstrate how MasterControl can help you with project visibility and organization using the latest in regulatory best practices.

Alex Butler, manager, Medical Device Solutions, MasterControl

3:00–3:45 pm  

A Notified Body’s Perspective – Managing the Impacts of EU IVDR and MDR


With the publication of the new IVD and MD regulations, regulatory professionals and device manufacturers are seeking clarification on how to implement the new requirements within their organizations. These new regulations tighten and strengthen the approval system and introduce several key changes that manufacturers will need to implement. This includes scope of regulated medical devices and IVDs, identification and traceability, premarket scrutiny procedure, and classification and conformity assessment requirements. Join this session and find out answers to the industry’s frequently asked questions for a better understanding of the key changes, impacts, transition phase and steps to be taken.

Nick Baker, medical devices technical manager, IVDR, LRQA