Design Control Snapshot: Advice About Design Change, Files, Inputs And More
• By Shawn M. Schmitt
From our digital archives: Device changes and design history files are integral aspects of design control that work hand-in-hand and should not be overlooked by manufacturers, industry experts said. Firms should keep copious records of design changes that can later be reviewed in a design history file (DHF); otherwise they could encounter what one expert dubbed “change creep.” This happens when a manufacturer makes numerous changes to a product, “and then all of a sudden we have a design that doesn’t even look like the original device,” John Gagliardi of MidWest Process Innovation said in December 2012. Further, firms should ensure that human factors are taken into consideration when design inputs are gathered.
Editor's note:"Quality Replay" digs into our rich digital archives for perennial insights on quality compliance topics. The full version of this article
first appeared in our former sister publication The Silver Sheet in December 2012. The content has been edited from...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.
