YOUR TRUSTED PARTNER IN MEDICAL DEVICE TESTING AND VALIDATION

The biocompatibility of medical devices, directed by ISO 10993-1, is a critical part of the medical device risk management process. This evaluation of risk consists of the biocompatibility component, but also multiple other mechanisms that work together to accurately predict medical device biocompatibility based on individual materials and use. The use of biological evaluation plans, chemical characterization testing, biocompatibility testing and toxicological risk assessment are all necessary components of the successful mitigation of biological risks. Quantum's medical device testing team is comprised of various experts, readily available to evaluate your device. These teams include chemists, material specialists, toxicologists and biocompatibility testing experts. Together, we can ensure that your safety evaluation plan minimizes unnecessary testing, maintains compliance with all pertinent standards and regulations and provides evidence for the ultimate goal of proving product safety.

Medical device sterilization validation studies are performed for all processes, including radiation sterilization by either gamma radiation or electron beam, ethylene oxide gas sterilization, hydrogen peroxide sterilization and thermal sterilization (both moist and dry heat). We are known for our ability to design custom protocols that not only meet clients’ testing budgets, but are also backed by a complete documentation package that fulfills all necessary regulatory requirements.