Matthew Hein, U.S. Department of Commerce

Should I Pursue Emerging Medtech Markets?

By MedTech Intelligence Staff

…those patient populations and the regulatory burdens more manageable, suggests Hein in the following video, which was filmed during the MedTech Intelligence Global Regulatory conference last week. https://www.youtube.com/watch?v=cSNS9fWitCg&feature=youtu.be    …

…those patient populations and the regulatory burdens more manageable, suggests Hein in the following video, which was filmed during the MedTech Intelligence Global Regulatory conference last week. https://www.youtube.com/watch?v=cSNS9fWitCg&feature=youtu.be    …

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

Management Review, Be Careful of What You Share

By Dr. Christopher Joseph Devine

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

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

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Laura Elan, UL

Increased Software Functionality Adding More Hurdles

By Maria Fontanazza

…another layer of complexity. Can manufacturers completely characterize all of the functional aspects within a software solution of such complexity? It will be important for manufacturers to have the ability…

…another layer of complexity. Can manufacturers completely characterize all of the functional aspects within a software solution of such complexity? It will be important for manufacturers to have the ability…

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ISO_13485

Answers: What’s Your ISO 13485 IQ?

By MedTech Intelligence Staff

…statement about ISO 13485: US FDA Requires manufacturers to comply with ISO 13485 It is the basis for the Health Canada CMDCAS program. – ANSWER. 63% answered correctly. It is…

…statement about ISO 13485: US FDA Requires manufacturers to comply with ISO 13485 It is the basis for the Health Canada CMDCAS program. – ANSWER. 63% answered correctly. It is…

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Regenerative Medicine

The Promise of Regenerative Medicine in Asia

By Ames Gross

…Western companies already have ventures in Japan underway because of Japan’s emphasis on regenerative medicine and the faster marketing process. Some company examples include Athersys, Pluristem, Mesoblast and RepliCel. Mesoblast,…

…Western companies already have ventures in Japan underway because of Japan’s emphasis on regenerative medicine and the faster marketing process. Some company examples include Athersys, Pluristem, Mesoblast and RepliCel. Mesoblast,…

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Federal Trade Commission

FTC Approves Final Order on Abbottā€™s Acquisition of St. Jude Medical

By MedTech Intelligence Staff

…if it plans to acquire the lesion-assessing ablation catheter assets from Advanced Cardiac Therapeutics (the two companies formed a partnership to develop these devices in the United States). https://medtechintelligence.com/news_article/medtech-powerhouse-abbott-to-acquire-st-jude-for-25-billion/  …

…if it plans to acquire the lesion-assessing ablation catheter assets from Advanced Cardiac Therapeutics (the two companies formed a partnership to develop these devices in the United States). https://medtechintelligence.com/news_article/medtech-powerhouse-abbott-to-acquire-st-jude-for-25-billion/  …

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

Crime Does Not Pay

By Dr. Christopher Joseph Devine

Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. “February 14, 2017: Two Miami-Dade women charged in connection with their operation of a spa performing illicit…

Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. “February 14, 2017: Two Miami-Dade women charged in connection with their operation of a spa performing illicit…

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Cybersecurity, mhealth

Cybersecurity Risks in Medical Devices Are Real

By Eric M. Luyer

…have hacked Dick Cheney’s heart”. The Washington Post. Retrieved from https://www.washingtonpost.com/news/the-switch/wp/2013/10/21/yes-terrorists-could-have-hacked-dick-cheneys-heart/?utm_term=.b66132885b11 “Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication”. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm535843.htm…

…have hacked Dick Cheney’s heart”. The Washington Post. Retrieved from https://www.washingtonpost.com/news/the-switch/wp/2013/10/21/yes-terrorists-could-have-hacked-dick-cheneys-heart/?utm_term=.b66132885b11 “Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication”. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm535843.htm…

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Medtech question

What’s Your ISO 13485 IQ?

By MedTech Intelligence Staff

ISO 13485, Medical devices–Quality management systems–Requirements for regulatory purposes, is a global standard that establishes requirements for a quality management system. Take this test to see how well you know…

ISO 13485, Medical devices–Quality management systems–Requirements for regulatory purposes, is a global standard that establishes requirements for a quality management system. Take this test to see how well you know…

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Laura Johnson, Loftware

5 Labeling Trends Affecting MedTech

By Laura Johnson

…necessary training and support. References Pettey, C. (2016). “Innovate Under Every Condition: The Bimodal Supply Chain,” Retrieved from http://www.gartner.com/smarterwithgartner/innovate-under-every-condition-the-bimodal-supply-chain/ Gartner IT Glossary. Retrieved from http://www.gartner.com/it-glossary/bimodal/. The annual survey referenced in…

…necessary training and support. References Pettey, C. (2016). “Innovate Under Every Condition: The Bimodal Supply Chain,” Retrieved from http://www.gartner.com/smarterwithgartner/innovate-under-every-condition-the-bimodal-supply-chain/ Gartner IT Glossary. Retrieved from http://www.gartner.com/it-glossary/bimodal/. The annual survey referenced in…

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