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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...
5 Ways to Leverage Castor’s API for Better Clinical Trials
eClinical systems must be flexible and adaptable to keep up with the ever-changing demands of modern clinical trials....
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...
What Will Trial Enrollment & Engagement Look Like in a Socially-Distanced World?
When the COVID-19 pandemic began, the industry needed to focus immediately on research continuity and determine how to...
Jumpstart Your Medical Device Preclinical Phase
The path to market for medical devices can be fraught with obstacles. One of the first challenges confronted...
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%...
How MedRhythms Captures Clinical Efficacy Data with Castor
MedRhythms used Castor's EDC and eCRF solutions to conduct their pivotal study. Castor's eCRF provides an instant snapshot...
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...
Protocol Deviations in Clinical Trials: Understanding the FDA’s Guidance
Protocol deviations can seriously impact the integrity of clinical trials, and with regulatory scrutiny growing, it’s crucial to...
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...
Three expected changes to FDA medical device approval
2019 was an interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul...
Impact of ISO 14155 on PMCF Investigations Under the MDR
Through the Medical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with...
Impact of COVID-19 and the Imminent MDR Delay
Introduction The implementation of the new EU Medical Device Regulation (MDR) just got a plot twist: COVID-19. This...
4 ways the Medical Device Regulation (MDR) will impact your device studies
Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As...
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