A Delay in MDR? Where are we now?
With the onset of the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) has been...
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...
In this webinar, we will share the latest trends in feedback received from the FDA concerning extractables...
The FDA’s expectations regarding the design of chemistry studies in support of medical device toxicology have been...
Understanding the latest trends in FDA feedback regarding extractables chemistry testing is crucial for ensuring compliance and...
During these unprecedented times, medical device companies have had to be exceptionally agile and responsive. During the...
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical...
Sterilizing medical devices via ethylene oxide (EO) gas is an effective and widely used practice within the...
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...