The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...
Over the next year, the term human factors must become very important to those who develop and market medical devices (if the term is not already). Developers must take a look at some common ...
Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time ...
Major processes in semiconductor wafer fabrication: 1) wafer preparation, 2) pattern transfer, 3) doping, 4) deposition, 5) etching, and 6) packaging. The process of creating semiconductors can be ...
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
New Book Shows How The Right Culture And Strategy Drive Breakthroughs In Drug And Device Development
NEW YORK (November 18, 2025) — Beyond the Science: How People, Process, and Systems Transform the Business of Life Sciences by Gary K. Zammit, PhD, is now available on Amazon and at major booksellers.
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 ...
Eclypsium security researchers have uncovered UEFI vulnerabilities in the Illumina iSeq 100 DNA sequencer, but the broader issue involves the device development process at large. In highlighting ...
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