CE Mark

Thinking of Transferring Your Notified Body? You’re Probably Not Alone

By Mark Leimbeck

…and maintain regulatory compliance and safety. The Net Effect This combination of fewer available competent and qualified staff to perform the increasing volume and complexity of work has had the…

…and maintain regulatory compliance and safety. The Net Effect This combination of fewer available competent and qualified staff to perform the increasing volume and complexity of work has had the…

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Neurostimulator, St. Jude Medical

St. Jude Medical Seeks to Address Excess Opioid Use with Technology

By Maria Fontanazza

…prescribed to patients suffering from chronic pain. According to The New England Journal of Medicine, opioids are the most commonly prescribed class of medications in America. Between 1991 and 2013,…

…prescribed to patients suffering from chronic pain. According to The New England Journal of Medicine, opioids are the most commonly prescribed class of medications in America. Between 1991 and 2013,…

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FDA

FDA’s Guidance Clears Up Factors, Benefits and Risks for IDE Submissions

By MedTech Intelligence Staff

…uncertainty may be offset by a variety of risk mitigation measures which can ensure appropriate patient and research participant protections in investigational research settings,” the guidance states. The guidance includes…

…uncertainty may be offset by a variety of risk mitigation measures which can ensure appropriate patient and research participant protections in investigational research settings,” the guidance states. The guidance includes…

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Medtech, innovation

Speedy and Efficient Implementation of Medical and Healthcare Software

By Richard Lu

…EHR Association backs no FDA regulation for electronic health record systems. Retrieved from http://www.healthcareitnews.com/news/ehr-association-backs-no-fda-regulation-electronic-health-record-systems NiQ Health. (July 30, 2014). Unregulated medical devices used extensively across Australian hospitals. Retrieved from http://www.careplus-niqhealth.com.au/news/niq-health-reveals-the-extensive-use-of-unregulated-medical-devices-in-australian-hospitals.html…

…EHR Association backs no FDA regulation for electronic health record systems. Retrieved from http://www.healthcareitnews.com/news/ehr-association-backs-no-fda-regulation-electronic-health-record-systems NiQ Health. (July 30, 2014). Unregulated medical devices used extensively across Australian hospitals. Retrieved from http://www.careplus-niqhealth.com.au/news/niq-health-reveals-the-extensive-use-of-unregulated-medical-devices-in-australian-hospitals.html…

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

Protect Your Establishment’s Equipment and QMS

By Dr. Christopher Joseph Devine

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

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

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FDA

FDA Wants Your Clinical Trials to Be More Diverse

By MedTech Intelligence Staff

…review boards (an independent committee of people that reviews research plans before research is conducted and once a year, at minimum, during the research). Further hindering patient participation is the…

…review boards (an independent committee of people that reviews research plans before research is conducted and once a year, at minimum, during the research). Further hindering patient participation is the…

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Alert

FDA Confirms Cybersecurity Vulnerabilities with Certain St. Jude Medical ICDs

By MedTech Intelligence Staff

Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…

Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…

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Ameing for Asia

Is the United States Really Tilting Toward Asia?

By Ames Gross

…were to put up new military bases closer to the Philippines, or threaten to invade the Philippines, President Duterte would immediately call the United States to protect them. Besides the…

…were to put up new military bases closer to the Philippines, or threaten to invade the Philippines, President Duterte would immediately call the United States to protect them. Besides the…

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Jacob Andra, U.S. Translation Company

Medical Innovation in an Age of Overregulation

By Jacob Andra

…and new product introduction.” Gallisa states that regulatory compliance makes up “25-35% of the cost of [medical device] goods.” The National Association of Manufacturers agrees. In its 2014 report, “The…

…and new product introduction.” Gallisa states that regulatory compliance makes up “25-35% of the cost of [medical device] goods.” The National Association of Manufacturers agrees. In its 2014 report, “The…

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Theranos Gets Rid of 41% of Staff

By MedTech Intelligence Staff

As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…

As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…

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