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By Thom Wyatt, Principal Engineer, Springboard | Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively. |
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By Allyson B. Mullen, Gail H. Javitt, and Philip Won | The FDA has issued a new proposed rule on laboratory-developed tests (LDTs), expressly defining LDTs as a type of in vitro diagnostic (IVD) device and subject to device regulations, including registration and listing, premarket review, and more. The FDA is accepting comments on the proposed rule through December 4. |
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By John Giantsidis, president, CyberActa, Inc. | The FDA had established a grace period for all medical device manufacturers to ensure that they are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, was October 1, 2023. Are you prepared? |
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