Chemical Characterization on a Combination Device for Biological Evaluation Plan to Practice
Join Dr. Annelies Vertommen and Dr. Sophie Michel in this insightful webinar as they delve into the...
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Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)
Throughout the COVID-19 crisis, there has been a significant emphasis on rapidly bringing critical products to the...
COVID-19, what we learned from the race to supply the market with respirators, masks, and other PPE
During these unprecedented times, medical device companies have had to be exceptionally agile and responsive. During the...
FDA Feedback Reguarding Chemistry for Toxicological Risk Assessment – How to Make Sure FDA will Accept Your Protocol
Understanding the latest trends in FDA feedback regarding extractables chemistry testing is crucial for ensuring compliance and...
Reprocessing Validations of Reusable Medical Devices
Reprocessing validations of reusable medical devices have often been neglected, with their importance underestimated until recently. However,...
Identifying and Mitigating Errors in Organic Extractables and Leachables Screening
The practice of Organic Chromatographic Screening, aimed at discovering, identifying, and (semi-)quantifying organic compounds in extracts from...
When drug meets device: How to assess compatibility?
The frequent use of combined products, which involve the joint application of drugs and medical devices, underscores...
The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device
Evaluating the biocompatibility of medical devices is a critical step in ensuring patient safety, and it should...
The Essence Of The EU MDR and its Key Consequences
The enhanced focus of the European Union Medical Device Regulation (EU-MDR) on biocompatibility and toxicity represents a...
ICH Stability Testing and Method Development
Stability testing is an essential component of product development, conducted throughout the entire lifecycle of a biotherapeutic...