Combination product, drug, device and biologic

Combination Products: FDA Releases Guidance on CGMP Requirements

By MedTech Intelligence Staff

…the rule, explains the role of the FDA centers related to any combination product CGMP matters, and gives hypothetical examples to show companies how to comply with the requirements. https://medtechintelligence.com/feature_article/special-problems-disconnects-combination-products/…

…the rule, explains the role of the FDA centers related to any combination product CGMP matters, and gives hypothetical examples to show companies how to comply with the requirements. https://medtechintelligence.com/feature_article/special-problems-disconnects-combination-products/…

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

Complaints, Complaints & Complaints: Is Anyone Listening?

By Dr. Christopher Joseph Devine

…activities. Observation one documents issues with the management of complaints. Because of the importance of complaints in the eyes of FDA, although compliance with the entire QSR is important, Dr….

…activities. Observation one documents issues with the management of complaints. Because of the importance of complaints in the eyes of FDA, although compliance with the entire QSR is important, Dr….

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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

…surgical center or hospital setting. On its own, this number looks gigantic, but if you compare it to a conventional back surgery or spinal fusion, it becomes very comparable, and…

…surgical center or hospital setting. On its own, this number looks gigantic, but if you compare it to a conventional back surgery or spinal fusion, it becomes very comparable, and…

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FDA

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

By MedTech Intelligence Staff

…provide this framework as part of the application. Other intents of the guidance document include: Enhancing predictability, consistency and transparency of the IDE review process To offer a common understanding…

…provide this framework as part of the application. Other intents of the guidance document include: Enhancing predictability, consistency and transparency of the IDE review process To offer a common understanding…

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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

…23–24, 2017 | LEARN MOREFDA has released a safety communication alerting physicians and patients to cybersecurity vulnerabilities related to St. Jude Medical’s radio frequency-enabled implantable cardiac devices and Merlin@home Transmitter….

…23–24, 2017 | LEARN MOREFDA has released a safety communication alerting physicians and patients to cybersecurity vulnerabilities related to St. Jude Medical’s radio frequency-enabled implantable cardiac devices and Merlin@home Transmitter….

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Ameing for Asia

Is the United States Really Tilting Toward Asia?

By Ames Gross

…Filipino delegation to Beijing to improve his country’s standing with China. China and the Philippines signed multiple agreements (business, energy, communications, and infrastructure) to their mutual benefit. Moreover, President Duterte…

…Filipino delegation to Beijing to improve his country’s standing with China. China and the Philippines signed multiple agreements (business, energy, communications, and infrastructure) to their mutual benefit. Moreover, President Duterte…

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