Synergia Bio Sciences assists biomedical and medical device companies in the necessary rationales to support Medical Devices classification and in the identification of the class of medical devices. Synergia Bio Sciences also participates in the elaboration and summary of product-related risk management plan, as well as in the elaboration of adapted product development plans (quality procedures, nonclinical testing, performance and/or clinical evaluation, labelling, instruction for use).
For innovative medical devices, Synergia Bio Sciences prepares and/or reviews Device Information Bulletins. Synergia Bio Sciences provides assistance with regulatory submissions (for clinical trials and for CE marking), with the establishment and maintenance of a medical device vigilance system. Our scope of services also includes selection and communication with Notified Bodies, and intense interfacing with Competent Authorities whenever necessary.