Medical Device Manufacturers
Whether you're designing medical devices or work in the quality systems, regulations, or software/cybersecurity fields, you're making a difference to ensure that clinicians and patients are utilizing health technology that is both safe and effective.
FDA Seeks Feedback on Medical Device Cybersecurity Threat Communication
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has issued an initial framework for communicating medical device cybersecurity vulnerability and threats to patients and caregivers.
Venous Self-Expanding Stent System Receives FDA Approval
The U.S. Food and Drug Administration has granted premarket approval (PMA) for a venous self-expanding stent system developed by Medtronic. The system, called Abre, is designed to help clear obstructions or compression deep in the veins that can cause restricted blood flow to the heart.
CMS Adds to Telehealth Services Covered During COVID-19
The Centers for Medicare & Medicaid Services (CMS) has expanded the list of telehealth services that Medicare Fee For Service will pay during the COVID-19 pandemic. The list of 11 services includes neurostimulator programming and monitoring, cardiac rehabilitation, and pulmonary rehabilitation.
Medical Device Software Validation (Mar24)
March 19 to 21, 2024
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (April24)
April 15 to 19, 2024
Production & Quality System Software (April24)
April 24 to 25, 2024
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User Experience and design thinking can be applied in every stage of the product design, development, marketing, and postmarket surveillance, writes a clinical engineer on the AAMIBlog.
Standards are developed through the coordination of volunteers from around the world just like you. They ensure the safe and effective production, distribution, and use of health technology.MORE INFO