Monali Bhansali
Soapbox

Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety

By Monali Bhansali

…include: Growing Complexity of Medical Devices: One of the biggest challenges in meeting regulatory requirements is the growing complexity of medical devices. This increasing complexity makes it difficult for manufacturers…

…include: Growing Complexity of Medical Devices: One of the biggest challenges in meeting regulatory requirements is the growing complexity of medical devices. This increasing complexity makes it difficult for manufacturers…

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Mother Earth graphic

Developing Sustainable Medical Devices

…is often where the work starts,” said Unger. “Set a target, communicate it companywide, and hold yourself accountable. One option is to create incentives.” Procurement Companies can commit to green…

…is often where the work starts,” said Unger. “Set a target, communicate it companywide, and hold yourself accountable. One option is to create incentives.” Procurement Companies can commit to green…

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Bret Ludwig, 3M
MEDdesign

Wearable Design Challenge: Stick-to-Skin Adhesion

By Bret Ludwig, Ph.D.

…years ago. With these advances, one commonly overlooked layer in the early stages of device development is the stick-to-skin adhesive. The Challenge of Sticking to Skin Ask a pressure sensitive…

…years ago. With these advances, one commonly overlooked layer in the early stages of device development is the stick-to-skin adhesive. The Challenge of Sticking to Skin Ask a pressure sensitive…

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Emily Newton, Revolutionized Magazine

Smart Hospitals: Five Technologies Upgrading the Industry

By Emily Newton

…providers to ensure patient safety even when healthcare personnel are not present. There are many different automated patient monitoring systems in development today. For example, researchers have applied AI computer…

…providers to ensure patient safety even when healthcare personnel are not present. There are many different automated patient monitoring systems in development today. For example, researchers have applied AI computer…

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Binary code
Soapbox

Automating Computer Systems Validation for Your QMS

By Davor Milosevic, Massimo Franza

…80% documentation and 20% testing. CSA also encourages companies to use vendor documentation to reduce testing burdens. To ensure a reliable validation outcome, FDA guidelines recommend defining a test strategy…

…80% documentation and 20% testing. CSA also encourages companies to use vendor documentation to reduce testing burdens. To ensure a reliable validation outcome, FDA guidelines recommend defining a test strategy…

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Patrizia Cavazzoni, M.D.

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

…interested parties in the medical products development community, such as pharmaceutical companies, ethicists, academia, patients and patient groups, and global counterpart regulatory and other authorities, on using AI/ML in drug…

…interested parties in the medical products development community, such as pharmaceutical companies, ethicists, academia, patients and patient groups, and global counterpart regulatory and other authorities, on using AI/ML in drug…

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FDA Logo

FDA Issues Draft Guidance on Use of Decentralized Clinical Trials

By MedTech Intelligence Staff

…event of a research-related injury. It should also describe who will have access to the trial participant’s personal health information obtained during the DCT. Stakeholders can submit comments on the…

…event of a research-related injury. It should also describe who will have access to the trial participant’s personal health information obtained during the DCT. Stakeholders can submit comments on the…

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Korey Johnson

How to Boost Patient Confidence Through Medical Device Design

By Korey Johnson

…more complex information and highlight critical safety information. But, of course, it is not always possible to communicate all facets of intended use via design affordances, especially for more complex…

…more complex information and highlight critical safety information. But, of course, it is not always possible to communicate all facets of intended use via design affordances, especially for more complex…

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John Kawola

The Role of 3D Micro Printing in Device Development

By MedTech Intelligence Staff

…neurovascular, the most common device used is a coil, where you can go in and choke off in aneurysm or a tumor, and there are a lot of small components…

…neurovascular, the most common device used is a coil, where you can go in and choke off in aneurysm or a tumor, and there are a lot of small components…

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