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CDRH Announces Radiation Sterilization Pilot Program

By MedTech Intelligence Staff

…sterilization master file pilot program for medical devices. The program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in…

…sterilization master file pilot program for medical devices. The program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in…

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Software and Artificial Intelligence as a Medical Device

By MedTech Intelligence Staff

The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in…

The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in…

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Jonathan Ripley

Process and Planning Are Key to Successful EU MDR PMS Compliance

By Jonathan Ripley

…general insights regarding off-label use. Competitor Activity – continuous tracking. The constant tracking of competitor and similar product performance not only makes good commercial sense, it provides fresh data for…

…general insights regarding off-label use. Competitor Activity – continuous tracking. The constant tracking of competitor and similar product performance not only makes good commercial sense, it provides fresh data for…

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Michael Earl
Soapbox

Digitalizing Drug Delivery ā€“ Whatā€™s Next?

By Michael Earl

…to create devices that work more effectively for different therapies, patient groups, and markets. [i] Biospace. (2022). Injectable Drug Delivery Market Size to Reach USD 83.38 Billion in 2030. https://www.biospace.com/article/injectable-drug-delivery-market-size-to-reach-usd-83-38-billion-in-2030-/?key%C2%ADwords=covid…

…to create devices that work more effectively for different therapies, patient groups, and markets. [i] Biospace. (2022). Injectable Drug Delivery Market Size to Reach USD 83.38 Billion in 2030. https://www.biospace.com/article/injectable-drug-delivery-market-size-to-reach-usd-83-38-billion-in-2030-/?key%C2%ADwords=covid…

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Brad Jolly
MEDdesign

Five Critical Considerations for Connected Health Manufacturers

By Brad Jolly

…on-board security controls and crash, deadlock, or freeze a device. To combat these threats, device manufacturers must implement a comprehensive testing mechanism called protocol fuzzing. The process injects various errors…

…on-board security controls and crash, deadlock, or freeze a device. To combat these threats, device manufacturers must implement a comprehensive testing mechanism called protocol fuzzing. The process injects various errors…

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3M Health To Collaborate with Amazon To Accelerate AI in Clinical Documentation

By MedTech Intelligence Staff

…3M will use AWS Machine Learning (ML) and generative AI services, including Amazon Bedrock, Amazon Comprehend Medical and Amazon Transcribe Medical, to help expedite and scale the delivery of 3M’s…

…3M will use AWS Machine Learning (ML) and generative AI services, including Amazon Bedrock, Amazon Comprehend Medical and Amazon Transcribe Medical, to help expedite and scale the delivery of 3M’s…

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Wiktoria Banczyk
MEDdesign

Ask the Expert: The Impact of IVD Regulations on Manufacturing

…bodies, who are responsible for assessing and certifying the compliance of IVD products with the new regulation. Notified bodies are expected to carry out more rigorous assessments of manufacturers’ compliance…

…bodies, who are responsible for assessing and certifying the compliance of IVD products with the new regulation. Notified bodies are expected to carry out more rigorous assessments of manufacturers’ compliance…

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Michael Keer

Selecting a Resilient Medical Device Contract Manufacturer for Long-term Success

By Michael Keer

…earthquakes, floods, or hurricanes. Regulatory Compliance Medical device OEMs operate in a heavily regulated environment, and compliance with requirements is critical to success. Therefore, the CM should have a comprehensive…

…earthquakes, floods, or hurricanes. Regulatory Compliance Medical device OEMs operate in a heavily regulated environment, and compliance with requirements is critical to success. Therefore, the CM should have a comprehensive…

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Sanobar Syed

Three Steps to Gain the Full Advantage of Pharmaceutical Business Forecasting

By Sanobar Syed

…which are high performers and hence create more revenue for the company. In many organizations, the role of business development (identifying and evaluating licensing, co-marketing, and co-promotion opportunities) relies upon…

…which are high performers and hence create more revenue for the company. In many organizations, the role of business development (identifying and evaluating licensing, co-marketing, and co-promotion opportunities) relies upon…

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FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices

By MedTech Intelligence Staff

…including software functions that are part of or control hardware medical devices,” said O’Leary. Stakeholders can submit comments on the draft guidance and download the full draft guidance document here….

…including software functions that are part of or control hardware medical devices,” said O’Leary. Stakeholders can submit comments on the draft guidance and download the full draft guidance document here….

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