Medical Devices

Clarios SpiroSphere® with wireless ECG- FDA 2024 clears, simplifying clinical trial data collection.

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Clarios

Clarios SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clarios SpiroSphere The FDA has granted 510(k) clearance for the COR-12 wireless ECG device, now seamlessly integrated with SpiroSphere®. This integration enables sponsors to conduct comprehensive respiratory trials while collecting cardiac safety ECG data using a single device. Clarios FDA-cleared SpiroSphere® integration with …

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FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests.

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DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests. DSCSA (Drug Supply Chain Security Act): On Wednesday, the US Food and Drug Administration (FDA) announced a two-year extension for small dispensers to comply with the enhanced tracking requirements of the Drug …

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Medical device equipment report suggests to enhance accessibility and cost-effectiveness of crucial medical device equipment.

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Medical device equipment: The report suggests strategies to enhance accessibility and cost-effectiveness of crucial medical device equipment. Medical device equipment Encouraging the local production of vital medical equipment, establishing a reliable logistics network and supplier system with strict quality control measures and certification standards, and implementing appropriate pricing strategies are highlighted as key methods to …

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Device surveillance he European Unions (MDCG) has released revised guidance on device surveillance-24

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Device surveillance the European Unions Medical Device Coordination Group (MDCG) has released revised guidance on device surveillance. Device surveillance The Medical Device Coordination Group (MDCG) has recently issued an updated version of its Surveillance Guidance for Medical Devices, bringing it in line with the transitional provisions outlined in EU regulations concerning medical devices and in …

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Introduction to CMC Compliance for Medical Devices 4 core and 5 elective

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Introduction to CMC Compliance for Medical Devices Introduction to CMC (Chemistry, Manufacturing, and Controls) compliance is a critical factor in the development and approval of medical devices. The CMC regulatory framework ensures that medical devices meet quality, safety, and efficacy standards before they are marketed for public use. CMC compliance guidelines are established by regulatory …

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Risk management for Medical Device and pharmaceuticals 024

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Risk management for medical device and pharmaceuticals  Risk management, to guarantee the security and effectiveness of medical equipment and prescription drugs, risk management is an essential procedure. We will provide a thorough rundown of risk management for these items in the sections that follow. Device Risk Management: The risk management procedure for medical devices typically …

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