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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Nicholas Lesniewski-Laas

Misconceptions of Miniaturization (Part 2): Smaller Packaging Yields Smaller Results

By Nicholas Lesniewski-Laas

…than the IC we’ve achieved a much more dramatic solution size reduction of 60%. For power electronics, the dependence upon external components or features can be easily seen by plugging…

…than the IC we’ve achieved a much more dramatic solution size reduction of 60%. For power electronics, the dependence upon external components or features can be easily seen by plugging…

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Nicholas Lesniewski-Laas

Misconceptions of Miniaturization (Part 1): Smaller is Better

By Nicholas Lesniewski-Laas

…where the users want to conserve bench space, as well as consumer goods, like smartphones. Internet polls of the most desired smartphone features often ask the users whether they want…

…where the users want to conserve bench space, as well as consumer goods, like smartphones. Internet polls of the most desired smartphone features often ask the users whether they want…

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