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

Trick or Treat

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 30, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579094.htm…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 30, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579094.htm…

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Ameing for Asia

Sports Medicine in Asia 2017

By Ames Gross

…Western Sports Medicine Companies in Asia Below are some examples of sports medicine companies already in Asia. Catapult Sports, based in Melbourne, Australia, is a leading athletic analytics company that…

…Western Sports Medicine Companies in Asia Below are some examples of sports medicine companies already in Asia. Catapult Sports, based in Melbourne, Australia, is a leading athletic analytics company that…

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

Dr. D Sees a Trend

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 23, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580281.htm…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 23, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580281.htm…

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Dan Reeve

Using Automation to Ease the Way for Medical Device Companies

By Dan Reeve

…having to adjust to new legislative and regulatory mandates, such as new EU medical device regulations passed earlier this year. Companies face ongoing pricing pressures, rapidly growing amounts of data…

…having to adjust to new legislative and regulatory mandates, such as new EU medical device regulations passed earlier this year. Companies face ongoing pricing pressures, rapidly growing amounts of data…

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Dalibor Pokrajac

New Interoperability Standards Drive Improvements In Management of Patient Care Devices

By Dalibor Pokrajac

…as HL7 or DICOM. The profiles define how to compose the messages relevant to a particular use case, so they can be interpreted by any other system that claims compatibility…

…as HL7 or DICOM. The profiles define how to compose the messages relevant to a particular use case, so they can be interpreted by any other system that claims compatibility…

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

Dr. D Hates Receiving Inspection, Say What?

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…

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Cybersecurity

Safeguarding Medical Devices Against Cyber-Attacks

By Anura Fernando

…about the prevalence of cybersecurity threats in medical devices. The fact that cybersecurity worries have now entered the medical device world shouldn’t come as too much of a surprise. In…

…about the prevalence of cybersecurity threats in medical devices. The fact that cybersecurity worries have now entered the medical device world shouldn’t come as too much of a surprise. In…

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Medtech, innovation

Wearables Revolutionize Classic Medicine

By Dr. Lutz Retzlaff

…physicians through a cloud solution. Precisely tailored wearables target diseases that include Alzheimer’s, Parkinson’s, asthma, cardiovascular diseases and diabetes; new options for monitoring newborns and pregnant women are also coming…

…physicians through a cloud solution. Precisely tailored wearables target diseases that include Alzheimer’s, Parkinson’s, asthma, cardiovascular diseases and diabetes; new options for monitoring newborns and pregnant women are also coming…

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Checkbox

The Ultimate QA/RA Cheat Sheet

By Thomas Maeder

…510(k) process, with timeline of communication In Vitro Diagnostics Office of In Vitro Diagnostics– Links to news and events, regulatory resources, and searchable IVD and CLIA databases Combination Products Office…

…510(k) process, with timeline of communication In Vitro Diagnostics Office of In Vitro Diagnostics– Links to news and events, regulatory resources, and searchable IVD and CLIA databases Combination Products Office…

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

Is Your Cleanroom Clean? Prove it!

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…

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