Michael Marquardt

Implementing MedTech Price Increases in Times of Inflation and EU MDR

By Michael Marquardt

…out, all important information should be compiled. Here it is advisable to involve all relevant market experts of the company and to use analyses of the market and competitive environment…

…out, all important information should be compiled. Here it is advisable to involve all relevant market experts of the company and to use analyses of the market and competitive environment…

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FDA Logo

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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Artificial Intelligence Graphic

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

for example, data privacy laws differ at both national and regional levels, creating barriers for companies looking to launch their products across multiple markets. Once we begin to navigate these…

for example, data privacy laws differ at both national and regional levels, creating barriers for companies looking to launch their products across multiple markets. Once we begin to navigate these…

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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 logo

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

…laboratory setting for general laboratory purposes such as sample preparation for subsequent analytic methods. A common example for GLU are pipettes. Vivaspin Ultrafiltration unit Sartorius Vivaspin® and Vivapore® ultrafiltration devices…

…laboratory setting for general laboratory purposes such as sample preparation for subsequent analytic methods. A common example for GLU are pipettes. Vivaspin Ultrafiltration unit Sartorius Vivaspin® and Vivapore® ultrafiltration devices…

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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

…including R&D forecasting, pipeline planning, revenue planning, sample and free goods, inventory, supply and production planning, resource and budget allocation, project prioritization, partnering decisions, compensation plans, and market access efforts….

…including R&D forecasting, pipeline planning, revenue planning, sample and free goods, inventory, supply and production planning, resource and budget allocation, project prioritization, partnering decisions, compensation plans, and market access efforts….

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