White papers & guides29 November 2022 2023 Guide to Clinical Data Collection under the EU Medical Device Regulation (EU MDR) Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this... Learn more
White papers & guides3 March 2022 Using APIs to enhance medical device data capture Application programming interfaces (API) are an essential feature of any clinical technology platform, saving researchers time and money Learn more
White papers & guides12 November 2021 Overview of EU Medical Device Regulations Medical device regulations in the EU have recently undergone a major overhaul. Learn the key tenets of MDR... Learn more
White papers & guides2 November 2021 How Medical Device Trials Can Benefit From Decentralized Methods In this whitepaper, we will look at how EDC, eConsent, ePRO, and APIs enable researchers to easily conduct... Learn more
White papers & guides14 May 2021 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... Learn more
White papers & guides26 January 2021 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... Learn more
White papers & guides30 November 2020 eBook: The Decentralized Clinical Trial Playbook This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote... Learn more
White papers & guides14 October 2020 Guide to using Electronic Data Capture (EDC) for Medical Device & Diagnostics Trials Download this guide to learn how to incorporating an Electronic Data Capture (EDC) system in your medical or... Learn more
White papers & guides18 August 2020 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... Learn more
White papers & guides30 June 2020 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... Learn more
White papers & guides16 June 2020 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... Learn more
White papers & guides19 May 2020 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... Learn more
White papers & guides5 May 2020 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... Learn more
White papers & guides28 April 2020 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... Learn more
White papers & guides21 April 2020 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... Learn more