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

Dirty Money Requires Some Laundering!

By Dr. Christopher Joseph Devine

…$2 million dollars. The good news is that Haley has already paid the United States $500,000. The bad news is that the Feds want more, more, more! Compliance for Dummies…

…$2 million dollars. The good news is that Haley has already paid the United States $500,000. The bad news is that the Feds want more, more, more! Compliance for Dummies…

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Footsteps

FDA to Develop More Guidance on Pre-Request for Designation Process

By MedTech Intelligence Staff

There’s some good news for manufacturers of combination products that deal with the confusion surrounding whether their product will be regulated as a device, drug, biologic or combination product. FDA…

There’s some good news for manufacturers of combination products that deal with the confusion surrounding whether their product will be regulated as a device, drug, biologic or combination product. FDA…

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

FDA and DOJ Working Together: No If, Ands or ‘Butts’!

By Dr. Christopher Joseph Devine

…a four-year prison sentence and was fined €75,000. Now the old doctor realizes that PIP is old news, and Mas has probably paid his debt to society. However, whenever the…

…a four-year prison sentence and was fined €75,000. Now the old doctor realizes that PIP is old news, and Mas has probably paid his debt to society. However, whenever the…

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

Temperature and Humidity Count, Who Knew?

By Dr. Christopher Joseph Devine

…(contact plates) testing is performed at defined intervals. In fact, the cleanroom really does need to be properly validated prior to use. The good news is there are establishments that…

…(contact plates) testing is performed at defined intervals. In fact, the cleanroom really does need to be properly validated prior to use. The good news is there are establishments that…

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CMS Slaps Theranos with Sanctions, Bans CEO from Running Labs

By MedTech Intelligence Staff

…April that the agency had initially suggested the ban. According to a Theranos news release, CMS sanctions include: Revoking Theranos’ Newark, California lab’s CLIA (Clinical Laboratory Improvement Amendments) certificate. This…

…April that the agency had initially suggested the ban. According to a Theranos news release, CMS sanctions include: Revoking Theranos’ Newark, California lab’s CLIA (Clinical Laboratory Improvement Amendments) certificate. This…

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Dollar, money

Medtech Powerhouse: Abbott to Acquire St. Jude for $25 Billion

By MedTech Intelligence Staff

…Miles D. White, chairman and CEO of Abbott in a news release. “The combined business will have a powerful pipeline ready to deliver next-generation medical technologies and offer improved efficiencies…

…Miles D. White, chairman and CEO of Abbott in a news release. “The combined business will have a powerful pipeline ready to deliver next-generation medical technologies and offer improved efficiencies…

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Wearable Cloud, Medical Device Connectivity

Adding Connectivity to Your Medical Device

By Eric Soederberg

…While the benefits are huge, the challenges are commensurately great. Cybersecurity. In recent months cybersecurity has topped the news and the worry list for healthcare providers (HCPs). In February, Blue…

…While the benefits are huge, the challenges are commensurately great. Cybersecurity. In recent months cybersecurity has topped the news and the worry list for healthcare providers (HCPs). In February, Blue…

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Soapbox

For Cost Cutting Measures, Look to Business Process Automation

By Steve Smith

…growth of regulatory burdens and global competition. The good news is that software as a service (SaaS) for business process management provides solutions that have a low cost of entry…

…growth of regulatory burdens and global competition. The good news is that software as a service (SaaS) for business process management provides solutions that have a low cost of entry…

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