Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of...
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Biocompatibility and the New MDR
This presentation will provide an in-depth overview of biocompatibility in compliance with the new Medical Device Regulations...
Navigating Packaging Changes in Light of New Regulatory Requirements
With the deadline for implementing the new Medical Device Regulation (MDR) fast approaching, it is crucial for...
Packaging Validations – A look at Current and Future State Testing
This Nelson Labs webinar will delve into the significant changes brought about by the release of the...
Designing an End-to-End Sterility Assurance Program
Sterility assurance for pharmaceutical products is of paramount importance, encompassing numerous aspects beyond the actual sterilization cycle...
MDR Effects on Cleaning and Sterilization Validations
The new Medical Devices Regulation (2017/745/EU) (MDR) aligns EU legislation with the latest technical advances, changes in...
Chemical Interactions between Leachables and Biopharmaceuticals
In the evaluation of pharmaceutical drug products, leachable compounds are typically assessed primarily for the toxicological risks...
Transportation and Distribution Testing for Medical Devices
An essential yet sometimes overlooked component of packaging shelf life validation is transportation and distribution testing. This...
Mass Extraction Container Closure “CCIT” for Rigid Containers
Mass extraction is a relatively new method for container closure integrity testing (CCIT) that has been included...
Biocompatibility: Applying the New ISO 10993 Standards
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...