Primary and Secondary Packaging Materials as Potential Source of Nitrosamines
Recently, several drug product recalls have occurred due to the unexpected presence of N-Nitrosamines. While the formation...
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Risk Assessment for Potential Elemental Impurities on Drug Products and Medical Devices
When submitting drug products for approval, regulatory authorities frequently ask, “Are you submitting your risk assessment for...
The Big Three: Cytotoxicity, Sensitization & Irritation Testing
Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the...
Hunt for N-nitrosamines in Medicinal Products
In the EMA newsletter published in September 2019, the pharmaceutical industry received a significant wake-up call regarding...
The Testing and Risk Management Impacts of Changing a Medical Device
Throughout its product life cycle, a medical device and its support system can undergo numerous changes—sometimes even...
Impact of MDR on Biocompatibility, a Shortage of Expertise
As the deadline for the Medical Device Regulation (MDR) approaches, many medical device manufacturers are rushing to...
Evaluating the biocompatibility of reusable medical devices during their whole life cycle
In the past, the primary focus for reusable medical devices was on validating reprocessing efficacy with regard...
MDR with Brexit_ How the Combination is Impacting the European Medical Device Industry
With the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) was delayed by one year....
Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation
The landscape of biocompatibility testing for medical devices is evolving with the recent shift of irritation assessment...
Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial
This is a crash course overview of medical device biocompatibility, designed to provide a comprehensive understanding of...