Identification of Pre-clinical Testing Requirements and Accredited Labs

We provide expert guidance in identifying the applicable pre-clinical tests required for medical devices, ensuring alignment with regulatory standards and facilitating a seamless pathway to market. The focus is on determining the specific tests based on the unique characteristics of the device, such as whether it is sterile, active, implantable, or software-based. Examples of preclinical tests include electrical safety and electromagnetic compatibility (EMC) evaluations, biocompatibility assessments (e.g., cytotoxicity, sensitization, and irritation testing), cybersecurity analysis, sterilization and cleaning validation, microbiological tests (e.g., bioburden and sterility), and stability or shelf-life studies. Additionally, we assist in identifying accredited laboratories with proven expertise to conduct these tests, guaranteeing reliable and regulatorycompliant results. With our support, navigating the complexities of pre-clinical testing requirements becomes efficient and straightforward.