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Instructional Materials: The Basis for Safety Between Users and Medical Devices

Leave a Comment / 04-Product Design & Development, 05-Quality/Regulatory, Care Delivery, end users, Home Health, human factors, instructional materials, ISO, Medical Device, medical devices, MedTech, patient safety, product design, RC - Device Design & Manufacturing / By

Instructional Materials: The Basis for Safety Between Users and Medical Devices     In the rapidly advancing world of medical devices, ensuring user safety and optimal performance is paramount. This calls for meticulous attention not only to the design of the devices themselves, but also to the instructional materials that accompany them. The efficacy of these …

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FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

Leave a Comment / AAMI, ethylene oxide, ISO, Medical Device, medical device sterilization, MedTech, Product Design & Development, Quality/Regulatory, RC - Medtech Regulatory Resource Center / By

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized …

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FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

Leave a Comment / AAMI, ethylene oxide, ISO, Medical Device, medical device sterilization, MedTech, Product Design & Development, Quality/Regulatory, RC - Medtech Regulatory Resource Center / By

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized …

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization Read More »

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

Leave a Comment / adaptive systems, AI, bias, data management, Digital Health, IEC, ISO, machine learning, Medical Device, MedTech, Quality/Regulatory, TIR34971 / By

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence     The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices. AAMI Technical Information Report (TIR)34971:2023, Application of ISO 14971 to machine …

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