Medical Device Regulation (MDR)

Post-market surveillance (also known as Post-Marketing Surveillance or PMS) refers to the requirement that manufacturers monitor their medical…

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.

Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this white paper.

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

The world may have changed seemingly overnight, but clinical research and medical innovation must continue now more than…

A recent report surveying representatives from the medical device industry across the world found that more than 55%…