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The Ultimate Guide to Post-Market Surveillance: What You Need to Know
In today’s rapidly evolving regulatory landscape, ensuring medical device safety and performance goes beyond the approval phase. Effective...
Essential Guide to Post-Market Clinical Follow-Up (PMCF) for Medical Devices
Learn the full impact of PMCF under the EU MDR and how to best prepare your medical device...
PMCF & RWE: Roles of Medical Device Registry Studies & ePROs
Registry studies focused on a specific medical device are a valuable tool to capture the safety and outcomes...
A Guide to Capturing and Managing Data in Digital Therapeutics Trials
This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote...
Why Remote Consent Is the New Normal in 2021
COVID-19 changed the conversation around enrollment and recruitment for clinical trials. Learn how eConsent is helping researchers do...
Top 4 eConsent Questions from Clinical Researchers
In September 2020, Castor CEO Derk Arts, MD, Ph.D., led a webinar on electronic informed consent (eConsent) challenges...
eBook: The Decentralized Clinical Trial Playbook
This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote...
UKCA Mark: 7 Steps to Prepare Medical Devices for Brexit
In the wake of Brexit, medical device companies secure a UKCA mark as proof of conformity to place...
eConsent – The Enrollment Solution for Decentralized Trials
Join this webinar to understand how eConsent works, where it falls in the regulatory guidelines & see a...
The Impact of ISO 14155 on PMCF Investigations Under the MDR
Download this white paper to prepare for the new MDR requirements requiring that PMCF investigations be conducted in...
An Expert Panel on Decentralized and Hybrid Trials, Pre and Post COVID-19
The world may have changed seemingly overnight, but clinical research and medical innovation must continue now more than...
A step-by-step tutorial on creating an approved PMCF plan
Under the MDR, PMCF activities will be mandated as part of medical device surveillance programs. These activities should...
6 essential steps to ensure MDR compliance before May 2021
A recent report surveying representatives from the medical device industry across the world found that more than 55%...
5 steps to meet PMCF requirements
Read the white paper to learn how Castor’s 5-step approach to PMCF can be used to fulfill MDR...
Satisfying PMCF requirements by utilizing IIS data
This white paper describes an approach that would enable medical device manufacturers to leverage anonymous data from IIS...
In-Vitro Diagnostic Regulation (IVDR): From oversight to overhead
The rising demand for early, accurate disease diagnosis and the growing possibilities in personalised medicine are driving the...
6 essential steps to ensure Medical Device Regulation (MDR) compliance before May 2021
July 17th 2020: This document has been updated to reflect regulatory changes in response to COVID-19. As this...
What does the Medical Device Regulation (MDR) tell us about Post-Market Surveillance?
With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for...