July 29, 2016
Consideration of human factors when designing a medical device should be a high priority. It is important that concerns regarding human factors are considered during the development phase of new medical devices. For many years, this phase of the process...
See BlogJuly 6, 2016
As anticipated, the United States Food and Drug Administration (US FDA) issued a new guidance document on the use of ISO 10993-1 on June 16, 2016. In one statement the FDA summarizes how they want to see biocompatibility for medical...
See BlogJune 16, 2016
FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking of FDA on the topic of ISO 10993-1 “Biological evaluation of medical devices – Part I: Evaluation and testing within...
See BlogMay 24, 2016
Posted in Printing Services by MDDI Staff on May 24, 2016 A new leapfrog guidance from FDA gives a glimpse into the agency’s thinking on 3D printed medical devices. On May 10, 2016, FDA released a leapfrog guidance document on the...
See BlogMarch 25, 2016
FDA is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. The Agency determined that an unreasonable and substantial risk of illness or injury may occur from using these medical products and...
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