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Medical Device Safety | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/medical-device-safety
    Medical Device Safety | FDA Medical Device Safety The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed...

Healthcare Equipment | Disinfection & Sterilization …

    https://www.cdc.gov/infectioncontrol/guidelines/disinfection/healthcare-equipment.html
    Medical equipment surfaces (e.g., blood pressure cuffs, stethoscopes, hemodialysis machines, and X-ray machines) can become contaminated with …

Cleaning | Disinfection & Sterilization Guidelines

    https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html
    The most common types of mechanical or automatic cleaners are ultrasonic cleaners, washer-decontaminators, washer-disinfectors, and washer-sterilizers. …

Validation and Verification for Medical …

    https://www.asme.org/topics-resources/content/validation-verification-for-medical-devices
    Two relatively recent standards—ISO’s IEC 62366:2007 “Medical Devices—Application of Usability Engineering to Medical Devices” and AAMI’s ANSI/AAMI …

Essential resource planning - World Health Organization

    https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/covid-19-critical-items
    The following catalogue lists all medical devices, including personal protective equipment, medical equipment, medical consumables, single use devices, laboratory and test …

What protocol needs to be followed to get a medical …

    https://www.fda.gov/industry/fda-basics-industry/what-protocol-needs-be-followed-get-medical-device-approved
    Or your product may be a medical device and is also an electronic radiation emitting product with additional requirements. STEP TWO is to determine how FDA may classify …

Medical Equipment Management Plan - Duke …

    https://www.safety.duke.edu/sites/default/files/Medical-Equipment-Management-Plan.pdf
    The Medical Equipment Management Plan defines the mechanisms for interaction and oversight of the medical equipment used in the diagnosis, treatment, and …

Medical Equipment, Devices, & Supplies - Joint …

    https://www.jointcommission.org/-/media/tjc/idev-imports/blogs/infection_control_presentationpdf.pdf?db=web&hash=A102FCA6C29749ACE7D445FF6AEC0FB4
    Puncture-resistant, leakproof, closable, impermeable Must be marked with a biohazard label or othermeans of identifying contaminated contents; ared bag or container mayalso …

Durable Medical Equipment, Prosthetics, Orthotics and …

    https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment
    Supplemental Medical Review Contractor (SMRC) Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Order Requirements Effective January …

CAN Protocols - Sterling Medical Devices

    https://sterlingmedicaldevices.com/our-work/medical-device-projects/can-protocols/
    Sterling Medical Devices participated in the development of Controller Area Network (CAN bus) protocols. These are typically used to facilitate the …



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