This seminar offers medical device manufacturers the opportunity to enhance efficiency and compliance by applying Lean Documentation and Lean Configuration principles. Led by expert Jose Mora, it ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Health care leaders may want to keep a closer eye on clinical validation for artificial intelligence (AI)-enabled medical devices (AIMDs), based on a recent JAMA Health Forum study.
Market opportunities include providing training and consulting services to medical device companies for FDA and EU MDR compliance, especially in design controls, verification and validation. This can ...
"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" is a guide for industry and FDA staff that identifies general factors to consider when validating reprocessing ...
Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing ...
LLC, a pioneer in sterilization assurance technology, is reinforcing its commitment to advancing sterilization science with a ...
Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...
WALDWICK, N.J.--(BUSINESS WIRE)--NextPhase Medical Devices LLC, a leading provider of electronic manufacturing services (EMS) and single-use disposable devices to leading medical device OEMs, recently ...
The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a ...
Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...
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