Preparing for Europeā€™s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Preparing for Europeā€™s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

By PTC Arena

Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution…

Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution…

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Hand holding globe - diversity

AdvaMed Releases New Resource on Diversity in Clinical Research

…of the trial sites and diversity of investigators. Understand the importance of building trust in recruiting diverse participants: between patients and clinicians, companies and clinical investigators/sites, and companies and communities….

…of the trial sites and diversity of investigators. Understand the importance of building trust in recruiting diverse participants: between patients and clinicians, companies and clinical investigators/sites, and companies and communities….

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Ruchi Thanawala

AI-Assisted Surgical Training

By Ruchi Thanawala, M.D.

…human pathologists to the machine learning (ML) robot that identified an ingredient commonly found in toothpaste that can fight malaria-based parasites, AI continues to surprise. Now, AI is being deployed…

…human pathologists to the machine learning (ML) robot that identified an ingredient commonly found in toothpaste that can fight malaria-based parasites, AI continues to surprise. Now, AI is being deployed…

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Lisa Hedges

Optimizing Wearables

By Lisa Hedges

…developing wearables. Even if you have the best UI/UX on the market, physical comfort is a top priority for consumers. Comfort can make or break your wearable from a business…

…developing wearables. Even if you have the best UI/UX on the market, physical comfort is a top priority for consumers. Comfort can make or break your wearable from a business…

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Sherry Parker, WuXi AppTec

Release Kinetics: An Important Element in Understanding Toxicological Risk of Chemical Constituents

By Sherry Parker, Ph.D.

…study focusing on a single compound of concern, but more often necessitates data generation through extractables/leachables (E/L) testing. For many medical devices, exhaustive and exaggerated extractions are recommended by ISO…

…study focusing on a single compound of concern, but more often necessitates data generation through extractables/leachables (E/L) testing. For many medical devices, exhaustive and exaggerated extractions are recommended by ISO…

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Inga Hansen, Managing Editor

Innovative Publishing Names Inga Hansen Managing Editor of MedTech Intelligence

…and associate editor of Dialysis & Transplantation. “Inga will be a strong addition to our team and will be responsible for growing our delivery of original in-depth reporting on important…

…and associate editor of Dialysis & Transplantation. “Inga will be a strong addition to our team and will be responsible for growing our delivery of original in-depth reporting on important…

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Bernstein_Mazur

Transforming Health Care: The Drive For Digital Health and Health IT

By Stephen Bernstein, Lisa Mazur

…healthcare technology, a busy regulatory environment and evolving consumer demands have combined to shape today’s digital health space. Examining the interplay of those factors can give us a glimpse into…

…healthcare technology, a busy regulatory environment and evolving consumer demands have combined to shape today’s digital health space. Examining the interplay of those factors can give us a glimpse into…

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Soapbox

Challenges Faced by Digital Therapeutics Developers

By Brian C. Rogers

…This second installment sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success. As a new technological course…

…This second installment sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success. As a new technological course…

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FDA CDRH Announces Reopening for All IVD Pre-Submissions

By MedTech Intelligence Staff

…agency received an “unprecedented number” of emergency use authorization (EUA) requests and pre-EUA submissions for COVID-19 tests and collection kits. These COVID-related devices were given priority, meaning that the CDRH…

…agency received an “unprecedented number” of emergency use authorization (EUA) requests and pre-EUA submissions for COVID-19 tests and collection kits. These COVID-related devices were given priority, meaning that the CDRH…

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Device Labeling MedAccred

MedAccred Program to Develop Labeling, Printing and UDI Audit Criteria Launched

By MedTech Intelligence Staff

…and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance,” said Limjaroen….

…and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance,” said Limjaroen….

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