CMMS Software: Enhancing Regulatory Compliance

By Donal Bourke

…optimizing maintenance management and ensuring regulatory compliance in the life sciences sector. Choosing the Right CMMS for Life Sciences In selecting a CMMS, it’s important to focus on: Compliance Features:…

…optimizing maintenance management and ensuring regulatory compliance in the life sciences sector. Choosing the Right CMMS for Life Sciences In selecting a CMMS, it’s important to focus on: Compliance Features:…

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Designing for the Future: How CGM Devices Are Adapting to Meet the Needs of a Growing User Base

By Chris Dawson

…device designs align with user needs while refining innovative features to adapt to the evolving demands of different user groups. Expanding Access and Broadening the User Base The CGM market…

…device designs align with user needs while refining innovative features to adapt to the evolving demands of different user groups. Expanding Access and Broadening the User Base The CGM market…

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Taking the Headache out of Maintaining 21 CFR Compliance

By Bryan Christiansen

…reminders and detailed maintenance procedures to ensure that all equipment is maintained according to FDA guidelines. Leading-edge solutions also offer robust security features that align with 21 CFR Part 11…

…reminders and detailed maintenance procedures to ensure that all equipment is maintained according to FDA guidelines. Leading-edge solutions also offer robust security features that align with 21 CFR Part 11…

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sustainable design

From design to disposal: Reducing the footprint of single-use drug delivery devices

By Alex Fong

…element within a reliably reuseable ‘shell’. Some drug delivery devices use connected features. These digital elements or connectivity to a drug delivery product, however, bring a new set of sustainability…

…element within a reliably reuseable ‘shell’. Some drug delivery devices use connected features. These digital elements or connectivity to a drug delivery product, however, bring a new set of sustainability…

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Japan Medical Device Reimbursement Update 2024

By Ames Gross

features and benefits. Please keep in mind that in many cases, you can have an MHLW device reimbursement meeting once the registration dossier is submitted, or sometimes even before that….

features and benefits. Please keep in mind that in many cases, you can have an MHLW device reimbursement meeting once the registration dossier is submitted, or sometimes even before that….

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Virtual care

AI-Enabled Healthcare: How Quality Engineering Needs to Evolve to Meet New Challenges

By Qualitest

…model; low stability or ability to adapt to new data; algorithmic or learned bias; or the use of sub-optimal features; these errors will prevent an AI initiative’s success. To detect…

…model; low stability or ability to adapt to new data; algorithmic or learned bias; or the use of sub-optimal features; these errors will prevent an AI initiative’s success. To detect…

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Risk Management in Medical Devices: Harmonizing ISO 14971-2019 & FDA QMSR

By Prasad Ravichandran 

…changes, safety features, and user training. Corrective Action & Preventive Action (CAPA) Process: QMSR requires manufacturers to implement a robust corrective and preventive action (CAPA) process. ​This process is essential…

…changes, safety features, and user training. Corrective Action & Preventive Action (CAPA) Process: QMSR requires manufacturers to implement a robust corrective and preventive action (CAPA) process. ​This process is essential…

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Errol Weiss

Information Sharing: A Valuable Tool in Preventing Cyber Attacks

By MedTech Intelligence Staff

…happen when these devices are deployed in the field. The reality is, you can’t just shut some of these devices off because there are life-saving features. On top of that,…

…happen when these devices are deployed in the field. The reality is, you can’t just shut some of these devices off because there are life-saving features. On top of that,…

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FDA Logo

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff

…that the device remains within its performance and safety specifications A description of error codes, alerts, and alarm features on the device Precautions, and warnings relevant to servicing the device…

…that the device remains within its performance and safety specifications A description of error codes, alerts, and alarm features on the device Precautions, and warnings relevant to servicing the device…

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Erez Kaminski, Keryx

UL Certification: A Launchpad for Product Development Excellence

By Erez Kaminski

…only can companies better empathize with its customers and tailor new features to their needs, but they can also deliver a better-quality product. Using your own products daily makes it…

…only can companies better empathize with its customers and tailor new features to their needs, but they can also deliver a better-quality product. Using your own products daily makes it…

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