Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK guidelines, and GAMP standards grants ...

Purpose: Validation of fluorescence in situ hybridization assays is required before using them in clinical practice. Yet, there are few published examples that describe the validation process, leading ...

A recent change in outlook at the U.S. Food and Drug Administration (FDA) — the government body that regulates the use of devices and substances in medical care — has escalated the already rigorous ...