Good 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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UncategorizedQuality Assurance Consultation
Understanding 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 10993-23:2021 – Biological Evaluation of Medical Devices – Part 23: Test for Irritation
The safety of biological evaluation is one important piece of the puzzle to demonstrate the safety of a medical device.
