MedTech Intelligence

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Thank you for including MTI. You will receive an email with a download link to the current Media Kit. Want to speak with a human? Contact RJ Palermo at RJ@innovativepublishing.net…

Thank you for including MTI. You will receive an email with a download link to the current Media Kit. Want to speak with a human? Contact RJ Palermo at RJ@innovativepublishing.net…

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Compliance Process

Change is the New Normal

By Huma.AI

…After EU MDR and IVDR—A Systematic Compliance Framework for Driving MedTech Innovation,” Edited by Bassil Akra, Ph.D. Download the full 60-page eBook here for free or purchase it on Amazon.com….

…After EU MDR and IVDR—A Systematic Compliance Framework for Driving MedTech Innovation,” Edited by Bassil Akra, Ph.D. Download the full 60-page eBook here for free or purchase it on Amazon.com….

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FDA

FDA Issues Cybersecurity Draft Guidance, Wants Devices Designed Securely

By MedTech Intelligence Staff

…FDA. Once finalized, the guidance aims to provide recommendations on cybersecurity considerations for medical devices; aid the industry in finding cybersecurity issues during the design and development process; and give…

…FDA. Once finalized, the guidance aims to provide recommendations on cybersecurity considerations for medical devices; aid the industry in finding cybersecurity issues during the design and development process; and give…

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Pradeep Goel, Solve.Care
Soapbox

Giving Control Back to the Patient

By Pradeep Goel

…of communication between healthcare professionals, especially when it comes to private and public healthcare facilities. There are examples of cancer patients moving between private and public facilities, and one healthcare…

…of communication between healthcare professionals, especially when it comes to private and public healthcare facilities. There are examples of cancer patients moving between private and public facilities, and one healthcare…

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Irritation Tests

Biocompatibility in MedTech: Irritation Tests with Skin Models

By Dr. Christoph D. Lindner

test method. New: Validated In-Vitro Test Methods Up to late 2020, the ISO 10993 series of standards (“Biological evaluation of medical devices”) comprised a total of 21 parts. In January…

test method. New: Validated In-Vitro Test Methods Up to late 2020, the ISO 10993 series of standards (“Biological evaluation of medical devices”) comprised a total of 21 parts. In January…

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Risk Logic

In Search of Flawless Devices

…After EU MDR and IVDR—A Systematic Compliance Framework for Driving MedTech Innovation,” Edited by Bassil Akra, Ph.D. Download the full 60-page eBook here for free or purchase it on Amazon.com….

…After EU MDR and IVDR—A Systematic Compliance Framework for Driving MedTech Innovation,” Edited by Bassil Akra, Ph.D. Download the full 60-page eBook here for free or purchase it on Amazon.com….

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Alert

FDA Issues Urgent Notice to Healthcare Providers Following Endoscope Recall

By MedTech Intelligence Staff

…the instructions for use and states that high-level disinfection and liquid chemical sterilization should not be used as reprocessing methods. Validation testing of these methods revealed that the “required efficacy…

…the instructions for use and states that high-level disinfection and liquid chemical sterilization should not be used as reprocessing methods. Validation testing of these methods revealed that the “required efficacy…

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FDA

FDA Seeks $60 Million in Funding to Improve Access to Safe and Effective Medical Products

By MedTech Intelligence Staff

…go towards a strategy for new and alternative methods for product testing in an effort to reduce animal testing. The FY budget covers October 1, 2022 through September 30, 2023….

…go towards a strategy for new and alternative methods for product testing in an effort to reduce animal testing. The FY budget covers October 1, 2022 through September 30, 2023….

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Joerg Schwarz, Infor
Soapbox

Why the Future of U.S. Patient Care Begins with Interoperability

By Joerg Schwarz, Ph.D.

…the possibility of a whole new set of opportunities. The pandemic was a catalyst for exploring alternate care settings, for example using remote monitoring with smart devices combined with televisits…

…the possibility of a whole new set of opportunities. The pandemic was a catalyst for exploring alternate care settings, for example using remote monitoring with smart devices combined with televisits…

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Etienne Nichols, Greenlight Guru
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols

…on the Preliminary Regulatory Impact Analysis for this proposed rule, the FDA estimated that there are approximately 4,445 companies that do not currently comply with ISO 13485. To those companies,…

…on the Preliminary Regulatory Impact Analysis for this proposed rule, the FDA estimated that there are approximately 4,445 companies that do not currently comply with ISO 13485. To those companies,…

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