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The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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This article shares key questions for your team to ask yourselves about demonstrating proof-of-concept with a functional prototype of your medical device.
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Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.
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The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
INDUSTRY INSIGHTS
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Design Verification Testing Of Combination Products
Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.
Sensor technologies embedded in catheters are enhancing surgical precision and real-time monitoring capabilities. Explore how these innovations are reshaping medical procedures and patient outcomes.
Discover the inner workings of solenoid valves, essential devices that control fluid and gas flow in diverse applications—from household appliances to advanced industrial systems.
Discover how these readers are setting a new standard for secure, hygienic access in environments where cleanliness is as critical as security.
Discover the rapid evolution and pivotal innovations driving the surge in vascular access catheter manufacturing. Explore the latest advancements shaping modern medical practices and patient care.
MED DEVICE ONLINE CONTENT COLLECTIONS
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Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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