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What is Irritation Testing?
A key component of biocompatibility testing is irritation testing, which directly assesses the potential of a material or product to cause localized irritation upon contact with sensitive tissues. Irritation testing is performed in vivo, and evaluates whether a...
What is Sensitization Testing?
Sensitization testing is designed to rule out the potential for allergic reactions that can result from exposure to a medical device, material, or pharmaceutical product. These delayed hypersensitivity reactions can occur when the body’s immune system identifies a...
Navigating Sterilization Strategy Transitions: Testing Considerations for Manufacturers
In today’s dynamic regulatory and supply chain landscape, more medical device and pharmaceutical manufacturers are exploring changes to their sterilization methods. These shifts are often driven by growing environmental concerns, evolving regulatory expectations, and...