CDRH Director Jeff Shuren, M.D. shared the secret to removing your company from FDA’s plan for routine inspections at the latest Case for Quality (CfQ) forum. The answer? Join the…
CDRH Director Jeff Shuren, M.D. shared the secret to removing your company from FDA’s plan for routine inspections at the latest Case for Quality (CfQ) forum. The answer? Join the…
…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/…
…(CRM) (b)(4) quality complaint reports for Class II devices are not reviewed by your Quality Department.” 21 CFR, Part 820.198 – Complaint Files “(c) Any complaint involving the possible failure…
…(CRM) (b)(4) quality complaint reports for Class II devices are not reviewed by your Quality Department.” 21 CFR, Part 820.198 – Complaint Files “(c) Any complaint involving the possible failure…
…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…
…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…
FDA published a final guidance to assist certain stakeholders with understanding what the agency takes into account when examining the risks and benefits of Investigational Device Submissions (ISE) for human…
FDA published a final guidance to assist certain stakeholders with understanding what the agency takes into account when examining the risks and benefits of Investigational Device Submissions (ISE) for human…
…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…
…that the compliance levels associated with failing to establish or comply with procedures is severe, then a warning letter will be in an offending establishment’s future (no crystal ball required)….
…that the compliance levels associated with failing to establish or comply with procedures is severe, then a warning letter will be in an offending establishment’s future (no crystal ball required)….
…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…
…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….
