Environmental Testing for Medical Devices
- Sterility Assurance: Our sterility testing services ensure that medical devices meet the highest standards of cleanliness and are free from harmful microorganisms. This includes validation of sterilization processes such as autoclaving, ethylene oxide, and radiation.
- Biocompatibility Testing: We conduct comprehensive biocompatibility assessments to verify that materials used in medical devices are safe for patient contact. Our tests adhere to ISO 10993 standards, covering cytotoxicity, sensitization, irritation, and more.
- Packaging and Shelf Life Studies: Ensure the integrity and longevity of your medical devices with our packaging validation and accelerated aging studies. We assess packaging materials and conditions to guarantee product stability and sterility throughout its lifecycle.
- Chemical Analysis: Our laboratory offers precise chemical analysis to detect and quantify residual chemicals, extractables, and leachables from medical device materials. This ensures compliance with regulatory standards and patient safety.
- Microbiological Testing: From environmental monitoring to microbial identification and endotoxin testing, we provide comprehensive microbiological services to ensure the safety and efficacy of medical devices.