Bilal Enes Okatar

I serve as an electrospinning subject matter expert (SME) with a focus on process and product development for electrospun cardiovascular Class III medical devices. My role encompasses: • Batch and process optimization to ensure robust, scalable, and compliant manufacturing • Execution of process-related root cause analyses (RCA) for deviations and nonconformities • Development and maintenance of process FMEAs (pFMEA) in accordance with Class III medical device regulatory requirements • Comprehensive data analysis of process inputs and outputs to verify compliance with defined specifications • Planning and execution of feasibility studies to support new product development and technology maturation

- Develop advanced vascular graft devices using electro-spun bioresorbable polymers to facilitate endogenous tissue restoration (ETR) in the next generation. - Create and implement deliverables associated with medical device design controls, including material specifications, drawings, design inputs, FMEAs, test plans, reports, and design verification activities. - Transform theoretical test concepts into practical applications. - Lead the design control aspects of the project. - Design and validate test methods and procedures for device qualification testing. - Establish project timelines and ensure the achievement of goals. - Collect and analyze data, prepare documentation, and propose recommendations for enhancements or changes. - Develop test protocols, reports, and supporting documentation for design verification purposes. - Collaborate closely with project team members in Operations, Regulatory, Quality, and Clinical departments to accomplish project objectives.

Investigating pharmaceutical active substances in the aim of testing in vitro against SARS-CoV-2 virus infection. Project was funded by TÜBİTAK and continues in Ankara University Stem Cell Research Institute.

Biomaterials, biosensors and tissue engineering