John Lehmann, Director of Business Development at IMARC Research In order to comply with applicable regulations and requirements, the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data integrity, and ensure that the trial conduct is in compliance with the clinical investigational plan (CIP), agreements, GCP, requirements […]
Saudi Arabia updates clearance policy for medical device shipments
By Stewart Eisenhart, Emergo Group The Saudi Food and Drug Authority (SFDA) has published an update to its requirements for clearance of medical device shipments at Saudi ports of entry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
The 10 most innovative medical devices of 2018
The nominees for the best medical technology of 2018 were recently announced for the 12th Annual Prix Galien USA Awards. The host of the awards, The Galien Foundation, awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Before the candidates can qualify […]
7 medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound […]
FDA increases medical device user fees in 2019
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrations including 510(k) and Premarket Approval (PMA) applications will increase for the agency’s 2019 fiscal year at a much slighter rate than for 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Analysis: Global medical device regulatory trends
By Evangeline Loh, Emergo Group In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
How to implement electronic Regulatory Binders in your study
Melissa Wollerman, Clinical Research Associate, IMARC Research In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now, almost five years later, many sites and sponsors have explored and implemented the electronic filing […]
7 medtech stories we missed this week: July 27, 2018
From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press release that it has received FDA clearance for its wireless LP1100 Life […]
China FDA adds more medical devices, IVDs to clinical trial exemptions list
By Teemo Chang and Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has drafted a new batch of medium- and high-risk medical devices and IVDs slated for exemption from clinical trial requirements in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
This engineered heart ventricle helps with studying arrhythmia and cardiomyopathy
While engineered heart tissues can replicate muscle contraction and electrical activity in a dish, many aspects of heart disease can only adequately be captured in 3D. In a report published online yesterday by Nature Biomedical Engineering, researchers describe a scale model of a heart ventricle, built to replicate the chamber’s architecture, physiology and contractions. Cardiac […]
Understanding the Medical Device Single Audit Program (MDSAP) audit process
Eamonn Hoxey, BSI Group The Medical Device Single Audit Program–MDSAP–was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS). Health Canada’s decision to require an MDSAP audit to maintain Canadian Device Licenses is leading to a rapid increase in use of the program. There is a […]
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