As an integrated part of the biological evaluation plan, SAXOCON are able to recommend relevant biological tests and toxicity studies to be performed. We work closely with accredited CROs to perform biological testing and ensure that their study design and reporting meets the necessary scientific standards and satisfies regulatory requirements. Results from these studies form part of our Biological Evaluation Reports for medical devices, and may be used to help qualify various safety endpoints or risks associated with the intended use of the device.
In addition, SAXOCON can initiate and monitor the outsourcing of further chemical analysis, in order to characterise potential levels of extractable and leachable substances. We maintain close relationships with competent analytical laboratories that specialise in material sciences and the conduct of extractable and leachable studies. We are able to provide recommendations on the test methods and analytical techniques employed and review the protocols and reports relevant for the evaluation of material components and overall characteristics of the finished product.