New Medical Device Regulation 745/2017 (MDR)

Open Letter on the Implementation and Readiness Status of the New Medical Device Regulation 745/2017 (MDR) Critical review of the new Medical Device Regulation from Medtech Europe. [pdf-embedder url="https://medical-grants.com/wp-content/uploads/2019/04/Medtech-Europe-open-letter_1555827960.pdf" title="Medtech Europe open letter_1555827960"] Source: https://www.linkedin.com/feed/update/urn:li:activity:6525149926949781504  

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Software as a Medical Device: FDA Update in May 2018

Until May 31, the U.S. Food and Drug Administration (FDA) has open for comment from the public a proposal for precertification of software as a medical device. Its 17-page proposal is located at https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm605685.pdf. Some trade press commentary is at http://www.mobihealthnews.com/content/fdas-pre-cert-plan-takes-shape-worries-emerge-about-overreach. This is part of FDA’s Digital Health Software Precertification (Pre-Cert) Program (https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm). Source: GARY CAPISTRANT, PATH Policy Advisor, Capistrant Consulting

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NIH Global mHealth Grant

Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21 Clinical Trial Optional) The purpose of this Funding Opportunity Announcement (FOA) is to encourage exploratory/developmental research applications that propose to conduct research to develop or adapt innovative mobile health (mHealth) technology specifically suited for low and middle income countries (LMICs) and determine the health-related outcomes associated with implementation of the technology. Of highest interest are innovative, well-designed multidisciplinary projects that aim to generate generalizable knowledge for the field. The overall goal of the FOA is to contribute to the evidence base for the use of…

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