Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions

By MedTech Intelligence Staff

…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…

…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…

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Leo Petrossian Head Shot
Soapbox

The Need for Global Standards in Digital Health Platforms

By Leo Petrossian

…to patients regardless of distance could transform and prolong these patients’ lives. However, new technology comes with risks. The increased use of virtual health care has raised questions of patient…

…to patients regardless of distance could transform and prolong these patients’ lives. However, new technology comes with risks. The increased use of virtual health care has raised questions of patient…

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FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions

By MedTech Intelligence Staff

…the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand and interpret the values provided by the quantitative imaging functions The FDA…

…the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand and interpret the values provided by the quantitative imaging functions The FDA…

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Garrett Schumacher

The Shifting Sands of Medical Device Cybersecurity Regulation

By Garrett Schumacher

…has the opportunity to influence the final guidance/requirements during the current review process by submitting comments and feedback. The comment period is open until July 7. HSCC Models the HDO…

…has the opportunity to influence the final guidance/requirements during the current review process by submitting comments and feedback. The comment period is open until July 7. HSCC Models the HDO…

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Preparing for Europe’s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Preparing for Europe’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

…representation in clinical research with the goal of reducing and eliminating health disparities. The insights in this new report come from a workshop series hosted by Meharry Medical College and…

…representation in clinical research with the goal of reducing and eliminating health disparities. The insights in this new report come from a workshop series hosted by Meharry Medical College and…

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Ruchi Thanawala

AI-Assisted Surgical Training

By Ruchi Thanawala, M.D.

…a very complex and simple place. While, on occasion, surgeons may use many tools to achieve a relatively straightforward goal, at other times, a complicated result may be produced with…

…a very complex and simple place. While, on occasion, surgeons may use many tools to achieve a relatively straightforward goal, at other times, a complicated result may be produced with…

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Lisa Hedges

Optimizing Wearables

By Lisa Hedges

Medical wearables have come a long way, from the first implantable pacemaker in 1958 to the first commercially approved glucose monitor in 1999. In fact, a recent publication on the…

Medical wearables have come a long way, from the first implantable pacemaker in 1958 to the first commercially approved glucose monitor in 1999. In fact, a recent publication on the…

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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

Inga Hansen is the new managing editor of MedTech Intelligence. She has more than 20 years’ experience in business-to-business healthcare media. Inga previously served as executive editor of MedEsthetics magazine…

Inga Hansen is the new managing editor of MedTech Intelligence. She has more than 20 years’ experience in business-to-business healthcare media. Inga previously served as executive editor of MedEsthetics magazine…

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