Src Designs & Associates company information, Employees & Contact Information

SRC Designs & Associates offers consulting services that enables US and EU market access for medical devices and drug/device combination product manufactures. We provide the bridge from quality data to build regulatory submission document packages. Leveraging our extensive experience in these fields, we facilitate this process efficiently while highlighting and minimizing business risk for our clients. Our methodology is to leveraging regional health authority regulations, guidance and recognized industry consensus standards for the US and EU to generate high quality GMP documentation deliverables that are summarized and attached into the submission framework. This process builds robust submission content for health authority review and consideration. We also offer to review clients Quality Management System to ensure it is able to produce the required regional document deliverables. We are able to counsel our clients from a compliance and market access submission perspective that is efficient, and value added for their organizations. We also offer to review clients Quality Management System to ensure it is able to produce the required regional document deliverables. We are able to counsel our clients from a compliance and market access submission perspective that is efficient, and value added for their organizations. Areas of Focus: Regulatory Strategy Program Management Quality Management Systems Design Controls and Product Realization Design Verification and Validation Human Factors Risk Management Product specifications