Soapbox

For Cost Cutting Measures, Look to Business Process Automation

By Steve Smith

…watching every cent of operating expenses, automating business processes like sales order management provides quick and tangible returns. Reference Emergo Group. 2016 Global Medical Device Industry Outlook. Retrieved from http://www.emergogroup.com/resources/research/outlook-medical-device-industry…

…watching every cent of operating expenses, automating business processes like sales order management provides quick and tangible returns. Reference Emergo Group. 2016 Global Medical Device Industry Outlook. Retrieved from http://www.emergogroup.com/resources/research/outlook-medical-device-industry…

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Finger prick lab tests, Theranos

Theranos CEO Holmes Expresses Devastation Over Lab Woes

By MedTech Intelligence Staff

…taking away Theranos’ federal license for its Newark, CA and Palo Alto, CA facilities (these labs generate the majority of the company’s revenue). This information was first reported by The…

…taking away Theranos’ federal license for its Newark, CA and Palo Alto, CA facilities (these labs generate the majority of the company’s revenue). This information was first reported by The…

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

Getting Fat on Form 483 Observations

By Dr. Christopher Joseph Devine

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 17, 2016). Inspections, Compliance, Enforcement, and…

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 17, 2016). Inspections, Compliance, Enforcement, and…

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Barcode, UDI

Don’t Wait to Comply with UDI

By Maria Fontanazza

companies may have the clear understanding of the UDI compliance requirements, they might not have adequate in-house resources to address all the tasks under the rule. Chatwin sat down with…

companies may have the clear understanding of the UDI compliance requirements, they might not have adequate in-house resources to address all the tasks under the rule. Chatwin sat down with…

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Ameing for Asia

Clinical Trials in Asia: Key Issues for Device Executives

By Ames Gross

International medical device companies are increasingly required to conduct local clinical trials for medical device approval in Asia. However, finding, qualifying, and selecting the right contract research organization (CRO) in…

International medical device companies are increasingly required to conduct local clinical trials for medical device approval in Asia. However, finding, qualifying, and selecting the right contract research organization (CRO) in…

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FDA, Al Taylor, Risk

FDA Says Consider Device Context, Not Just Intended Use

By MedTech Intelligence Staff

…at last month’s MedTech Intelligence conference on risk management and risk acceptability. Taylor added that while this concept isn’t written into regulation, “to me, it’s just common sense.” https://youtu.be/tHGZcZU5FJg  …

…at last month’s MedTech Intelligence conference on risk management and risk acceptability. Taylor added that while this concept isn’t written into regulation, “to me, it’s just common sense.” https://youtu.be/tHGZcZU5FJg  …

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

Innocent Until Proven Guilty

By Dr. Christopher Joseph Devine

…into commerce without first obtaining clearance from the FDA. Entering medical devices into U.S. commerce without the benefit of clearance or approval from the FDA is always going to end…

…into commerce without first obtaining clearance from the FDA. Entering medical devices into U.S. commerce without the benefit of clearance or approval from the FDA is always going to end…

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Dollar, money

This Week’s Big Acquisition: Sterigenics Picks Up Nelson Laboratories

By MedTech Intelligence Staff

…testing services will be combined with Nelson Labs, creating the largest fully integrated sterilization and lab services firm worldwide, according to a press release from Sterigenics. The combined entities will…

…testing services will be combined with Nelson Labs, creating the largest fully integrated sterilization and lab services firm worldwide, according to a press release from Sterigenics. The combined entities will…

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Medtronic Micra

First Vitamin-Sized Leadless Pacemaker Hits U.S. Market

By MedTech Intelligence Staff

…an electrode at the end of the device. The device received a CE Mark in April 2015. Take a look at the evolution in size of Medtronic’s pacemaker technology: https://medtechintelligence.com/news_article/medtronics-european-research-center-focuses-on-innovation-for-survival/…

…an electrode at the end of the device. The device received a CE Mark in April 2015. Take a look at the evolution in size of Medtronic’s pacemaker technology: https://medtechintelligence.com/news_article/medtronics-european-research-center-focuses-on-innovation-for-survival/…

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mHealth apps, FDA, FCC, regulations

FDA and FCC Release Mobile Health App Tool

By MedTech Intelligence Staff

…creates or shares consumer information; or diagnoses or treats a disease or condition, for example. It’s also possible that regulations from more than one agency will apply. The mHealth app…

…creates or shares consumer information; or diagnoses or treats a disease or condition, for example. It’s also possible that regulations from more than one agency will apply. The mHealth app…

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