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Transitioning Research Projects to In-vitro. Transitioning a research project to the product. Implementation of a Quality Management System (QMS). Higher level of regulatory compliance (FDA QSR/ISO13485). Formation of a Product Development team. Scientists trained to function in QMS. Application of Project Management process. Creates focused timelines to meet objectives and deliverables. Development of a risk management plan. Identifies areas of risk where mitigation plans are required.

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