…test method. New: Validated In-Vitro Test Methods Up to late 2020, the ISO 10993 series of standards (“Biological evaluation of medical devices”) comprised a total of 21 parts. In January…
…test method. New: Validated In-Vitro Test Methods Up to late 2020, the ISO 10993 series of standards (“Biological evaluation of medical devices”) comprised a total of 21 parts. In January…
…After EU MDR and IVDR—A Systematic Compliance Framework for Driving MedTech Innovation,” Edited by Bassil Akra, Ph.D. Download the full 60-page eBook here for free or purchase it on Amazon.com….
…After EU MDR and IVDR—A Systematic Compliance Framework for Driving MedTech Innovation,” Edited by Bassil Akra, Ph.D. Download the full 60-page eBook here for free or purchase it on Amazon.com….
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods….
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods….
…with a goal of developing a “more comprehensive” program that helps identify and mitigate vulnerabilities. In addition, the funding will help the FDA hire more staff to recruit and develop…
…with a goal of developing a “more comprehensive” program that helps identify and mitigate vulnerabilities. In addition, the funding will help the FDA hire more staff to recruit and develop…
…when she commented that data sharing is essential for value- based care, but providers stuck in fee-for-service models, where volume of service is king, do not like to share data….
…when she commented that data sharing is essential for value- based care, but providers stuck in fee-for-service models, where volume of service is king, do not like to share data….
…on the Preliminary Regulatory Impact Analysis for this proposed rule, the FDA estimated that there are approximately 4,445 companies that do not currently comply with ISO 13485. To those companies,…
…on the Preliminary Regulatory Impact Analysis for this proposed rule, the FDA estimated that there are approximately 4,445 companies that do not currently comply with ISO 13485. To those companies,…
…the company stated, “It is not necessary to remove affected Philips V60/V60 Plus ventilators from service.” Thus far there have been no reports of injuries, adverse events or patient deaths…
…the company stated, “It is not necessary to remove affected Philips V60/V60 Plus ventilators from service.” Thus far there have been no reports of injuries, adverse events or patient deaths…
…can have on compliance efforts, which are set to remain high up the business agenda as further regulations arrive in the coming years. The need for digital assistance is clearly…
…can have on compliance efforts, which are set to remain high up the business agenda as further regulations arrive in the coming years. The need for digital assistance is clearly…
…devices have become a prominent part of daily life, and most notably for patients who are managing chronic conditions. Although commercial devices such as the Fitbit or Apple Watch are…
…devices have become a prominent part of daily life, and most notably for patients who are managing chronic conditions. Although commercial devices such as the Fitbit or Apple Watch are…
…but now is connected may no longer be supported or technologically costly or infeasible to remediate, too. In cases when a patch is unavailable, some type of compensating control must…
…but now is connected may no longer be supported or technologically costly or infeasible to remediate, too. In cases when a patch is unavailable, some type of compensating control must…
