Innovation in the medical products industry requires a planned staged approach from conceptual design to finished product. Our experts will help guide your Pre-Clinical In Vitro and In-Vivo testing to evaluate your products, including writing pre-clinical test protocols and the development of test plans for bench, animal, biocompatibility, and toxicity testing within the requirements of current standards and guidelines. Once your testing is completed, we review and write test reports for inclusion in regulatory submissions.
In conjunction with a pre-clinical test plan process, a strategic approach should be taken with implementing your Quality System. BBA’s philosophy for developing quality systems is centered on what are the least burdensome requirements to be met at each phase of your company throughout the product development process. We ensure systems are compliant to the necessary regulations, while not encumbering you with overly unwieldy systems. Our approach is focused on putting systems in place during the following three phases of product development:
In the steps to product approval, a well-defined risk management plan must also be developed, implemented and updated throughout the design process. Your unique product development process must be focused on mitigating the risks your product potentially possesses in order to provide the maximum benefit. Assisting clients in the management of product risk has allowed us to develop a broad and detailed understanding of ISO standards, FDA Guidance documents, and regulatory expectations for a multitude of medical products. We will partner with you to define, develop, document, and deliver a pre-clinical strategy that will bring your product to market, encompassing all aspects of product validation and verification.