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Medical Devices

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.

Synergia Bio Sciences delivers:
Determination of regulatory strategy
Determination of regulatory status for biologics, and writing of appropriate rationales
IProduct related risk management
Data review and recommendations on development plan, and its implementation
Focus on specific testing to perform with combination products
Program management for the implementation of clinical trials protocol and CRF design, regulatory submissions, investigator identification
Close monitoring of pilot studies
Liaison between sponsors, Notified Bodies and Competent Authorities
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