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...
Join Dr. Annelies Vertommen and Dr. Sophie Michel in this insightful webinar as they delve into the...
The frequent use of combined products, which involve the joint application of drugs and medical devices, underscores...
Evaluating the biocompatibility of medical devices is a critical step in ensuring patient safety, and it should...
The enhanced focus of the European Union Medical Device Regulation (EU-MDR) on biocompatibility and toxicity represents a...
Starting with a biocompatible material is crucial for medical device manufacturers. However, regulatory requirements are pushing manufacturers...
The 2018 revision of ISO 10993-1 aligns closely with the Medical Device Regulation (MDR) to provide clearer...
