Asia

Demand Skyrockets for Oncology Products in Asian Markets

By Ames Gross

…of cancers. Both lifestyle cancers that are associated with the wealthy as well as infection-based cancers that mainly affect the poor are common across Asia. Out of all cancer cases…

…of cancers. Both lifestyle cancers that are associated with the wealthy as well as infection-based cancers that mainly affect the poor are common across Asia. Out of all cancer cases…

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UL LLC

Ask the Expert: EU Regulations and Clarification for Products Used in Day Spas

…used in the workplace to be certified to recognized standards. You can read more on the standards that apply to Beauty Therapy products in the UL white paper at: http://library.ul.com/?document=safety-of-personal-hygiene-beauty-therapy-equipment-used-in-commercial-settings…

…used in the workplace to be certified to recognized standards. You can read more on the standards that apply to Beauty Therapy products in the UL white paper at: http://library.ul.com/?document=safety-of-personal-hygiene-beauty-therapy-equipment-used-in-commercial-settings…

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How to CE Mark a Medical Device that Incorporates a Drug

By Paula McCarthy

…consult a Competent Authority before taking a decision on providing CE Mark certification. The manufacturer must compile a comprehensive dossier clearly describing the quality, safety and usefulness of the drug…

…consult a Competent Authority before taking a decision on providing CE Mark certification. The manufacturer must compile a comprehensive dossier clearly describing the quality, safety and usefulness of the drug…

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Could the Pope Give You a Heart Attack?

By Maria Fontanazza

Those who have been in the presence of the pope often describe the experience as deeply emotional and quite overwhelming. But could these feelings actually cause a heart attack? Probably…

Those who have been in the presence of the pope often describe the experience as deeply emotional and quite overwhelming. But could these feelings actually cause a heart attack? Probably…

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

Only Two Form 483 Observations Can Equate to a Warning Letter

By Dr. Christopher Joseph Devine

…take short cuts and as Larry the Cable Guy routinely pontificates, “Get’er Done!” Furthermore, oral complaints are complaints, and they shall be documented accordingly. Finally, as part of the complaint…

…take short cuts and as Larry the Cable Guy routinely pontificates, “Get’er Done!” Furthermore, oral complaints are complaints, and they shall be documented accordingly. Finally, as part of the complaint…

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Top Procurement Strategies to Enhance Profitability

To remain competitive in today’s global marketplace, the smartest medical device manufacturers are broadening their perspectives when it comes to contract manufacturing strategies for new product introductions. They are moving…

To remain competitive in today’s global marketplace, the smartest medical device manufacturers are broadening their perspectives when it comes to contract manufacturing strategies for new product introductions. They are moving…

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Jessica Holmes, Argenta Advisors
Reimbursement Report

The Best Value Proposition. Ever.

By Jessica Holmes

Any life science company that is not actively defining or redefining its technology’s value proposition—appealing to payers’ wants while addressing customer needs—risks losing a competitive edge to companies that are…

Any life science company that is not actively defining or redefining its technology’s value proposition—appealing to payers’ wants while addressing customer needs—risks losing a competitive edge to companies that are…

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

If Hackers Can Commandeer a Car, Why not a Medical Device?

By Dr. Christopher Joseph Devine

…selection/input. (October 2012). Accessed August 3, 2015. Retrieved from http://www.fda.gov/safety/recalls/ucm326131.htm Symbiq Infusion System by Hospira: FDA safety communication – cybersecurity vulnerabilities. (July 2015). Accessed July 31, 2015. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456832.htm…

…selection/input. (October 2012). Accessed August 3, 2015. Retrieved from http://www.fda.gov/safety/recalls/ucm326131.htm Symbiq Infusion System by Hospira: FDA safety communication – cybersecurity vulnerabilities. (July 2015). Accessed July 31, 2015. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456832.htm…

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Alert

Hack Alert: Infusion Pump Security at Risk

By MedTech Intelligence Staff

System. On Friday FDA issued a safety communication alert related to this product and advised any healthcare facilities that are currently using it to “transition to alternative systems”. The issue:…

System. On Friday FDA issued a safety communication alert related to this product and advised any healthcare facilities that are currently using it to “transition to alternative systems”. The issue:…

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What Do FDA Investigators Look for During an Inspection?

By Maria Fontanazza

…Drayton spoke about the considerations of inspections specifically related to combination products during MedTech Intelligence’s Combination Products in June. While FDA investigators are trained to look at the big picture…

…Drayton spoke about the considerations of inspections specifically related to combination products during MedTech Intelligence’s Combination Products in June. While FDA investigators are trained to look at the big picture…

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