Design Change Impact on Biocompatibility and Documentation
Change management in the design of medical devices is a critical process, frequently highlighted in FDA 483...
Change management in the design of medical devices is a critical process, frequently highlighted in FDA 483...
Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the...
Throughout its product life cycle, a medical device and its support system can undergo numerous changes—sometimes even...
As the deadline for the Medical Device Regulation (MDR) approaches, many medical device manufacturers are rushing to...
With the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) was delayed by one year....
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
With the onset of the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) has been...
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
The FDA’s expectations regarding the design of chemistry studies in support of medical device toxicology have been...
In this webinar, we will share the latest trends in feedback received from the FDA concerning extractables...