Medical Devices

In today’s rapidly evolving regulatory landscape, ensuring medical device safety and performance goes beyond the approval phase. Effective…

Learn the full impact of PMCF under the EU MDR and how to best prepare your medical device studies.

Registry studies focused on a specific medical device are a valuable tool to capture the safety and outcomes of the device over its lifetime. Read more here.

This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote interactions in their clinical studies.

This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote interactions in their clinical studies.

In the wake of Brexit, medical device companies secure a UKCA mark as proof of conformity to place their device on the UK market. Learn what this means for your organization and how to prepare.

Download this guide to learn how to incorporating an Electronic Data Capture (EDC) system in your medical or diagnostics device trials.

The following is an excerpt from our free whitepaper ‘Satisfying PMCF requirements by utilizing IIS data’. Click here…

Join this webinar to understand how eConsent works, where it falls in the regulatory guidelines & see a practical demonstration of eConsent software.

Download this white paper to prepare for the new MDR requirements requiring that PMCF investigations be conducted in compliance with ISO 14155.