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

Rodents in the Workforce, Oh My!

By Dr. Christopher Joseph Devine

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and Criminal…

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and Criminal…

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Medtronic, CardioInsight

Medtronic Wins FDA Clearance for First Noninvasive Cardiac Electrical Mapping System

By MedTech Intelligence Staff

…is providing the first commercial noninvasive solution for this approach with the CardioInsight Noninvasive 3D Mapping System. The technology received 510(k) approval from FDA and can be used to map…

…is providing the first commercial noninvasive solution for this approach with the CardioInsight Noninvasive 3D Mapping System. The technology received 510(k) approval from FDA and can be used to map…

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Niall Redmond, Starfish Medical
MEDdesign

Adding the Human Factor to Medical Devices

By Niall Redmond

…importance and level of mental preparation required and how that pertains to the accepted level of comfort. Another important criteria while designing for comfort is understanding how long the comfort…

…importance and level of mental preparation required and how that pertains to the accepted level of comfort. Another important criteria while designing for comfort is understanding how long the comfort…

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Build an Effective Global Regulatory Strategy

By Laura Elan, Linda M. Chatwin, Esq, RAC

…the Global Regulatory Strategy Conference, February 28–March 1, 2017 | Attend in-person in Washington, D.C. or virtually | LEARN MOREThe global regulatory landscape presents varied compliance issues, requirements, accepted test

…the Global Regulatory Strategy Conference, February 28–March 1, 2017 | Attend in-person in Washington, D.C. or virtually | LEARN MOREThe global regulatory landscape presents varied compliance issues, requirements, accepted test

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Latin America, medtech

The State of the Latin American Market for Medical Devices

By Jacob Andra, Rachel Gaines

…year. Booming Subsectors Some of the more noteworthy medical device growth sectors include breathing aid technology, x-ray and vital sign equipment. In Mexico, for example, the market for breathing aid…

…year. Booming Subsectors Some of the more noteworthy medical device growth sectors include breathing aid technology, x-ray and vital sign equipment. In Mexico, for example, the market for breathing aid…

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

Response Not Adequate, Ouch!

By Dr. Christopher Joseph Devine

…to ensure their establishments remain in compliance with all applicable quality, regulatory and statutory requirements. Remember, the word compliance is not some neologism (look-it-up). Additionally, compliance is not just another…

…to ensure their establishments remain in compliance with all applicable quality, regulatory and statutory requirements. Remember, the word compliance is not some neologism (look-it-up). Additionally, compliance is not just another…

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Trumpā€™s Gag Order on Federal Agencies Hits HHS, NHS

By MedTech Intelligence Staff

…its regular communication channels with the public, the media and other relevant audiences.” Departments across agencies are concerned about potential secrecy of the Trump administration and the freedom of information…

…its regular communication channels with the public, the media and other relevant audiences.” Departments across agencies are concerned about potential secrecy of the Trump administration and the freedom of information…

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Myanmar

Myanmarā€™s Medtech on the Rise as Market Opens Up

By Ames Gross

…private hospitals. Newer technologies such as 3-D and 4-D ultrasounds will also significantly improve diagnostic procedures. High quality tests and early disease detection needs will provide Western companies with many…

…private hospitals. Newer technologies such as 3-D and 4-D ultrasounds will also significantly improve diagnostic procedures. High quality tests and early disease detection needs will provide Western companies with many…

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Footsteps

Remediation: What Challenges Do Device Companies Face?

By Maria Fontanazza

…industry or business size—the common denominator is risk. What can companies do to not just reduce risks, but prevent them from occurring in the first place? Download this comprehensive guidebook…

…industry or business size—the common denominator is risk. What can companies do to not just reduce risks, but prevent them from occurring in the first place? Download this comprehensive guidebook…

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