FDA's QMSR and Synchronization with ISO 13485:2016: Insights from Document 89 FR 7496
In medical device regulation, the adherence to stringent quality management standards is pivotal. Regulatory bodies such as the U.S. Food...
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- Jul 19
Verification vs. Validation in Immunoassay and In Vitro Diagnostics
In the field of immunoassays and in vitro diagnostics (IVD), ensuring the accuracy and reliability of tests is paramount. These...
- Jul 10
Harnessing Bioconjugation for Therapeutic Advancements
In modern medicine, the field of bioconjugation has emerged as a powerful tool for advancing therapeutic applications. By combining...
- Jul 3
Navigating the Sensitivity vs. Specificity Dilemma in In Vitro Diagnostics
In vitro diagnostics (IVD) are pivotal tools in healthcare, aiding in disease diagnosis, monitoring, and treatment decisions. However,...
- Jun 11
Quality Control in Immunoassay Development to Ensure Reliable Results
In the realm of biomedical research and clinical diagnostics, immunoassays play a pivotal role in detecting and quantifying biomolecules...
- May 17
Scope Creep from IVDR into Regulated Bioanalysis
As industries evolve, so do regulations governing them. The In Vitro Diagnostic Regulation (IVDR) was introduced to enhance the safety...
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