STATISTICS 101: TYPES OF DATA
An understanding of statistics is useful whenever you are anaylsing any types of data and want to take actions based […]
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UncategorizedMed Device Quality Consulting
WHO Prequalification of In-Vitro diagnostics
WHO PQ: What, How, and WHY? The World Health Organisation Prequalification (WHO PQ) programme helps countries with low and medium-level
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UncategorizedBlog on Biomaterials
Thanks to their adaptability, resilience, and cost-effectiveness, biomaterials have long been a mainstay in medical device manufacturing. However, the environmental
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UncategorizedGOOD DOCUMENTATION PRACTICES
Good Documentation Practices (GDP) serve as the foundational elements of a robust Quality Management System. Mandated by numerous regulatory bodies,
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UncategorizedUnderstanding the ISO 80369 Standards for Medical Connectors
Small-bore connectors, which have an opening size of less than 8.5 mm, are essential components in various medical devices used
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UncategorizedISO 10993ISOISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Test for irritationISO 10993ISO
The safety of biological evaluation is one important piece of the puzzle to demonstrate the safety of a medical device.
Sterilization of Medical Devices
Medical device sterilization is essential to maintain the safety of patients and healthcare professionals. Improperly sterilized medical devices can produce
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