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

Sixteen Form 483 Observations. Ouch!

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 November 6, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580196.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 November 6, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580196.htm…

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Ameing for Asia

Medical Software Regulations in Asia 2017

By Ames Gross

…Pilot Program’ to streamline the approval process for a select number of medical software companies. In September 2015, the European Commission (EC) issued a guidance paper for determining the status…

…Pilot Program’ to streamline the approval process for a select number of medical software companies. In September 2015, the European Commission (EC) issued a guidance paper for determining the status…

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William H. Honaker, member, Dickson Wright

Patent Litigation: Avoiding A Nightmare

By William H. Honaker

…Association “2017 Report of the Economic Survey” stated that the median cost to litigate a patent case is $3,000,000. In addition to the out-of- pocket costs, there are also the…

…Association “2017 Report of the Economic Survey” stated that the median cost to litigate a patent case is $3,000,000. In addition to the out-of- pocket costs, there are also the…

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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

…companies, which are looking to accelerate processing times, reduce errors and complexity, enhance visibility and reduce costs to adapt to a highly regulated, competitive and price-conscious market. As organizations transform…

…companies, which are looking to accelerate processing times, reduce errors and complexity, enhance visibility and reduce costs to adapt to a highly regulated, competitive and price-conscious market. As organizations transform…

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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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