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MedTech Intelligence

Volume 14 Issue No. 30

 

Brian Stallard, AAMIMan vs. Machine—Or More of a Partnership?

By Brian Stallard, AAMI

Is technology replacing the human element in hospitals and clinics, or enhancing it? In this AAMI Research Review, a pair of newly published studies exemplify how accounting for the humans that use a technology can enhance its effectiveness … and vice versa.

 

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Featured Articles

Soapbox

IoMT and 5G Are Changing the Face of Healthcare Delivery

By Emily Newton, Revolutionized magazine

The growing availability of 5G networks is speeding the adoption of IoMT and allowing for new innovations, including drone delivery of medical supplies to rural areas, better surgical collaboration and 3D holograms for diagnoses and surgical planning.

COMPLIMENTARY ON DEMAND WEBINAR

DistillerSRLiterature Reviews Strategies for Post-Market Surveillance
A Best Practices Webinar

Sponsored By DistillerSR

Post-market surveillance (PMS) is a requirement for medical device manufacturers and a critical element of EU MDR. In this webinar roundtable, Sara Garbin of the Sleep and Respiratory Care Unit (SRC) at Philips and Bassil Akra from Akra Team GmbH, reflect on challenges and opportunities for medical device companies conducting post-market surveillance as part of their compliance path.

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FDA Issues Final Guidance on UDI Compliance Policy and
Extends Enforcement Deadline

By MedTech Intelligence Staff

The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.

Pria Healthcare - Accelerating Healthcare Innovation

NIST Seeks Feedback on New Guidance for Healthcare Cybersecurity

By MedTech Intelligence Staff

The revised cybersecurity draft publication is not intended to be a checklist for healthcare organizations to follow, but rather a guide to help them comply with the HIPAA Security Rule.

Construction Begins on U.S.-based Lateral Flow Membrane
Production Facility

By MedTech Intelligence Staff

MilliporeSigma received a $136.7 million contract award from the U.S. Department of Defense (DoD), on behalf of the U.S. Department of Health and Human Services (HHS), to support the new facility. It will be the company’s first U.S.-based facility capable of producing diagnostic-grade membrane.

MedTech Library

Adapting to COVID-19 with simulation in the medical device industryAdapting to COVID-19 with simulation in the medical device industry

Sponsored By Siemens

Learn how medical device manufacturers are using simulation to enhance their design process to help fight COVID-19 and continuously innovate.

6 Requirements for Medical Device Manufacturers in 20226 Requirements for Medical Device Manufacturers in 2022

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Discover the 6 key requirements to consider when executing your digital transformation strategy and learn how to turn uncertainty and disruption into a model for sustainable growth.

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

Sponsored 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 can help simplify compliance.

 Launching your medical device: A strategy & execution cross-functional guideLaunching your medical device:
A strategy & execution cross-functional guide

Sponsored By Definitive Healthcare

Learn how the experts launch their medical devices. Definitive Healthcare’s eBook cowritten by Carl Zeiss Meditec Inc. is packed with checklists and descriptions of all major pre-launch action items each team in your org needs to complete to successfully launch your device.

Unified Medical Imaging Solutions:
The Next Evolution in Imaging

Sponsored By Arrow and Dell Technologies

The Rise of Implantable Devices

Sponsored By AMETEK-COINING

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