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

A Device with no DHF is a Bad Thing in the Eyes of FDA

By Dr. Christopher Joseph Devine

…External testing (e.g., sterilization validation, package testing, and biocompatibility testing) Product labeling (including IFUs and user manuals) DMRs Any other document or record relevant for supporting the design and development…

…External testing (e.g., sterilization validation, package testing, and biocompatibility testing) Product labeling (including IFUs and user manuals) DMRs Any other document or record relevant for supporting the design and development…

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Boston Scientific

Boston Scientificā€™s Strategy in Acquiring Symetis: Beef Up TAVI

By MedTech Intelligence Staff

…products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings…

…products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings…

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EpiPen auto-injector, recall

Worldwide Recall on EpiPens Expanded

By MedTech Intelligence Staff

…recall information on its website for information on the product return and replacement process (call Stericycle at 877-650-3494). FDA has a list of the U.S. impacted lots on its website….

…recall information on its website for information on the product return and replacement process (call Stericycle at 877-650-3494). FDA has a list of the U.S. impacted lots on its website….

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Rafael Mazuz, Diligence Wound Care Global

How to Assess and Select Biomedical Distributors in Emerging and Frontier Markets

By Rafael Mazuz

complementary call points/products, engagement of the company leadership, and level of English (or the primary language of communication). Also, if you look closely at “good” market assessments or business plans…

complementary call points/products, engagement of the company leadership, and level of English (or the primary language of communication). Also, if you look closely at “good” market assessments or business plans…

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Stress

Feeling Stressed? Thereā€™s a Device for That

By MedTech Intelligence Staff

The fast-paced American lifestyle is a constant stressor for people. While a day at the spa is a solution for many, one company has developed a mechanical solution with the…

The fast-paced American lifestyle is a constant stressor for people. While a day at the spa is a solution for many, one company has developed a mechanical solution with the…

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Cybersecurity

Medtech Cybervangelists Hack Several Critical Care Devices

By MedTech Intelligence Staff

…educational forum for FDA. He expressed concern over the challenges that device companies face in cybersecurity, indicating industry does not have the level of expertise necessary to address the dangers…

…educational forum for FDA. He expressed concern over the challenges that device companies face in cybersecurity, indicating industry does not have the level of expertise necessary to address the dangers…

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UL Logo

UL Receives Transition for Accreditation for ISO 13485:2016

After completing its assessment, UL has received accreditation by the Standards Council of Canada as a registrar under the latest version of ISO 13485:2016 and ISO 13485:2016 under CMDCAS.The 2016…

After completing its assessment, UL has received accreditation by the Standards Council of Canada as a registrar under the latest version of ISO 13485:2016 and ISO 13485:2016 under CMDCAS.The 2016…

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Alert

Experimental Balloon Procedure Puts Patients at Risk

By MedTech Intelligence Staff

An alert recently went out regarding an experimental procedure that uses balloon angioplasty devices outside the scope of the agency’s approved indications for use. Transvascular autonomic modulation involves the threading…

An alert recently went out regarding an experimental procedure that uses balloon angioplasty devices outside the scope of the agency’s approved indications for use. Transvascular autonomic modulation involves the threading…

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Susan Alpert, SFA Consulting, Global Regulatory Strategy

Practical Advice for Your Regulatory Strategy

By MedTech Intelligence Staff

…by MedTech Intelligence. In the following video, Alpert offers three key points companies should consider when building a global regulatory strategy: Go where the patients are, plan for critical markets,…

…by MedTech Intelligence. In the following video, Alpert offers three key points companies should consider when building a global regulatory strategy: Go where the patients are, plan for critical markets,…

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

Recipient of Illegal Buttock Injection Dies

By Dr. Christopher Joseph Devine

…are unconscionable. However, there is also a need for better public awareness about the risks associated with illegal silicone injections. Unfortunately, common sense can become a fleeting virtue when it…

…are unconscionable. However, there is also a need for better public awareness about the risks associated with illegal silicone injections. Unfortunately, common sense can become a fleeting virtue when it…

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