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

Rodents in the Workforce, Oh My!

By Dr. Christopher Joseph Devine

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Beyond Technology Corporation Nanchang. Accessed January 22, 2017. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515336.htm…

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Beyond Technology Corporation Nanchang. Accessed January 22, 2017. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515336.htm…

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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

…down to the subjectivity of comfort and how to design for it. Human Factors and Patient Comfort There are many ways to design for comfort, but first you need to…

…down to the subjectivity of comfort and how to design for it. Human Factors and Patient Comfort There are many ways to design for comfort, but first you need to…

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Build an Effective Global Regulatory Strategy

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

…seeking market access across multiple marketplaces. Since small and medium-sized entities comprise the majority of companies in the medical device industry, the impact to costs and lead times can be…

…seeking market access across multiple marketplaces. Since small and medium-sized entities comprise the majority of companies in the medical device industry, the impact to costs and lead times can be…

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Latin America, medtech

The State of the Latin American Market for Medical Devices

By Jacob Andra, Rachel Gaines

…the four major non-communicable diseases (cardiovascular disease, most cancers, diabetes and chronic respiratory diseases) will cause 81% of deaths in Latin America by 2030. Understandably alarmed, Latin American leaders have…

…the four major non-communicable diseases (cardiovascular disease, most cancers, diabetes and chronic respiratory diseases) will cause 81% of deaths in Latin America by 2030. Understandably alarmed, Latin American leaders have…

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

Response Not Adequate, Ouch!

By Dr. Christopher Joseph Devine

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. A.R.C.O.S., Srl. Accessed January 22, 2017. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515195.htm…

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. A.R.C.O.S., Srl. Accessed January 22, 2017. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515195.htm…

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Trump’s Gag Order on Federal Agencies Hits HHS, NHS

By MedTech Intelligence Staff

…guidances until they undergo review by his administration. An HHS official called media reports “erroneous”, stating “HHS and its agencies continue to communicate fully about its work through all of…

…guidances until they undergo review by his administration. An HHS official called media reports “erroneous”, stating “HHS and its agencies continue to communicate fully about its work through all of…

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Myanmar

Myanmar’s Medtech on the Rise as Market Opens Up

By Ames Gross

…companies are experiencing success in Myanmar. According to a 2013 report by BioPharm, Indian drug companies held 35%-40% of the pharmaceutical market, and foreign investment will continue to grow. In…

…companies are experiencing success in Myanmar. According to a 2013 report by BioPharm, Indian drug companies held 35%-40% of the pharmaceutical market, and foreign investment will continue to grow. In…

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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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FDA Shares the Secret to Stopping Inspections

By Daniel R. Matlis

…Case for Quality movement and demonstrate that your company provides patients access to high quality, safe and effective medical devices. To succeed, your company must share the FDA goal to…

…Case for Quality movement and demonstrate that your company provides patients access to high quality, safe and effective medical devices. To succeed, your company must share the FDA goal to…

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