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...
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Materials Qualification of Healthcare Products to Radiation Sterilization
Newer medical products, particularly those that are biological in nature or composed of materials sensitive to traditional...
Pharma Packaging Considerations for Radiation Processing using Gamma and Electron Beam and Discussion on the New Container Closure Integrity Testing
This webinar is designed to enhance your foundational knowledge of pharmaceutical packaging, particularly focusing on its critical...
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...
Biocompatibility of Raw Materials for Medical Devices
Starting with a biocompatible material is crucial for medical device manufacturers. However, regulatory requirements are pushing manufacturers...
The New ISO 10993 – 18 Standard and its Impact on Chemical Characterization of Medical Devices
In response to the heightened focus on chemical characterization outlined in ISO 10993-1:2018, a significant revision of...
Changes to ISO10993-1 and relationship to Medical Device Regulation
The 2018 revision of ISO 10993-1 aligns closely with the Medical Device Regulation (MDR) to provide clearer...