Employee Coaching

CDRH Seeks Medical Device Sites for Review Staff Education

By MedTech Intelligence Staff

To help reviewers keep pace with rapid advances in medical devices and technologies, the FDA’s Center for Devices and Radiological Health (CDRH) developed the Experiential Learning Program (ELP). ELP provides…

To help reviewers keep pace with rapid advances in medical devices and technologies, the FDA’s Center for Devices and Radiological Health (CDRH) developed the Experiential Learning Program (ELP). ELP provides…

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Leon Hendra

The Case for In-Person Work: Making Human Connections

By Leon Hendra

…or maintain some form of remote work with an eye towards retention. Subscribe to the weekly MedTech Intelligence newsletter to stay up to date on the latest news and information…

…or maintain some form of remote work with an eye towards retention. Subscribe to the weekly MedTech Intelligence newsletter to stay up to date on the latest news and information…

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Jordanna Jayne

Realizing the Promise of Real-World Evidence in MedTech

By Jordanna Jayne, Ph.D.

…pandemic to enable faster transition of Emergency Use Authorization (EUA) products to full marketing authorization. However, scientific hurdles remained in order to objectively use RWD. The good news is, scientific…

…pandemic to enable faster transition of Emergency Use Authorization (EUA) products to full marketing authorization. However, scientific hurdles remained in order to objectively use RWD. The good news is, scientific…

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Blood pressure

Tonometry Superior for Cuffless Blood Pressure Monitoring

A study from Microsoft Research, published in the July 2022 IEEE Journal of Biomedical and Health Informatics, highlighted to need for more demographically diverse populations and challenging evaluation settings when…

A study from Microsoft Research, published in the July 2022 IEEE Journal of Biomedical and Health Informatics, highlighted to need for more demographically diverse populations and challenging evaluation settings when…

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Garrett Schumacher
MEDdesign

Velentium Launches Medical Device Cybersecurity Course with University of Colorado

Students at the University of Colorado Boulder had a new course offering and introduction to the medtech industry via a partnership between the University and Velentium, a Houston-based engineering firm…

Students at the University of Colorado Boulder had a new course offering and introduction to the medtech industry via a partnership between the University and Velentium, a Houston-based engineering firm…

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MilliporeSigma

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

By MedTech Intelligence Staff

A new U.S.-based facility dedicated to the manufacturing of lateral flow membranes for rapid diagnostic test kits is under construction. This month, MilliporeSigma, the U.S. and Canada Life Science business…

A new U.S.-based facility dedicated to the manufacturing of lateral flow membranes for rapid diagnostic test kits is under construction. This month, MilliporeSigma, the U.S. and Canada Life Science business…

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NIST Graphic

NIST Seeks Feedback on New Guidance for Healthcare Cybersecurity

By MedTech Intelligence Staff

The National Institute of Standards and Technology (NIST) has updated its cybersecurity guidance for the healthcare industry. The new draft publication, “Implementing the Health Insurance Portability and Accountability Act (HIPAA)…

The National Institute of Standards and Technology (NIST) has updated its cybersecurity guidance for the healthcare industry. The new draft publication, “Implementing the Health Insurance Portability and Accountability Act (HIPAA)…

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Brian Stallard, AAMI

Man vs. Machine—Or More of a Partnership?

By Brian Stallard

…technology and sterilization from AAMI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on MedTech design and development. “The variable-pitch…

…technology and sterilization from AAMI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on MedTech design and development. “The variable-pitch…

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FDA

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

By MedTech Intelligence Staff

On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document,…

On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document,…

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Jabil Team Photo

JABIL Cayey Receives MedAccred Plastics Injection Molding Accreditation

Puerto Rico-based Jabil Cayey has achieved MedAccred Accreditation for Plastics Injection Molding, meeting the audit requirements set by the subscribing member companies of the MedAccred program, including: Bausch Health, Baxter,…

Puerto Rico-based Jabil Cayey has achieved MedAccred Accreditation for Plastics Injection Molding, meeting the audit requirements set by the subscribing member companies of the MedAccred program, including: Bausch Health, Baxter,…

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