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 ...
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
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 ...
Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
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 ...