Holst Centre, Eindhoven, Electronics

Smaller Electronics Push Possibility of Wearable Devices

By Maria Fontanazza

…that the company’s goal is for the 400 million people who suffer from incontinence globally to be free of the condition. LifeSense has already had its first sales and started…

…that the company’s goal is for the 400 million people who suffer from incontinence globally to be free of the condition. LifeSense has already had its first sales and started…

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Combination product, drug, device and biologic

Two Key Processes You Must Know as a Combination Product Manufacturer

By David Amor

…streamline new product submissions. The recent trend of pharmaceutical companies acquiring medical device start-ups to supplement their R&D pipeline and expand combination product innovations continues. Teva Pharmaceuticals recently acquired Gecko…

…streamline new product submissions. The recent trend of pharmaceutical companies acquiring medical device start-ups to supplement their R&D pipeline and expand combination product innovations continues. Teva Pharmaceuticals recently acquired Gecko…

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MEDdesign

Science Fiction Meets Nano-Robots

By Klaus Jopp

…retinal diseases. Using OCT it is possible to obtain 3-D images of the composition of tissue structures. Compared to other techniques, the technique involves a high level of penetration depth…

…retinal diseases. Using OCT it is possible to obtain 3-D images of the composition of tissue structures. Compared to other techniques, the technique involves a high level of penetration depth…

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Digital Health Hot Topic at RAPS 2015

By Maria Fontanazza

…massive amount of healthcare data coming its way, advised Jump. With this flood of data come connectivity issues, changing quality system and compliance expectations on a global level, and software…

…massive amount of healthcare data coming its way, advised Jump. With this flood of data come connectivity issues, changing quality system and compliance expectations on a global level, and software…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The Number 13 Proves Unlucky for California Establishment

By Dr. Christopher Joseph Devine

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Lusys Laboratories, Inc. Accessed October 26, 2015….

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Lusys Laboratories, Inc. Accessed October 26, 2015….

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Finger prick lab tests, Theranos

FDA Says Theranos Device Uncleared, Finds Host of Problems

By Maria Fontanazza

Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation….

Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation….

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2015 Update on the Diabetes Market In Asia

By Ames Gross

…20% of the company’s global diabetes revenues. There are plenty of opportunities for small-to-medium size businesses to make inroads in Asia as well. For example, Echo Therapeutics, based in New

…20% of the company’s global diabetes revenues. There are plenty of opportunities for small-to-medium size businesses to make inroads in Asia as well. For example, Echo Therapeutics, based in New

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UL LLC

China Stiffens Software Requirements for Medical Devices

…medical devices, stand alone, or proprietary. We are excited to share with you the completion of our latest article “Big Changes for CFDA Software Requirements” written by UL Technical Consultant

…medical devices, stand alone, or proprietary. We are excited to share with you the completion of our latest article “Big Changes for CFDA Software Requirements” written by UL Technical Consultant

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

FDA Takes Design Validation Seriously

By Dr. Christopher Joseph Devine

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Banyan Medical, LLC. Accessed October 19, 2015….

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Banyan Medical, LLC. Accessed October 19, 2015….

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