About
Our Services
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Rx Device Consulting offers comprehensive services to support every stage of the product lifecycle, from concept to market. We specialize in regulatory strategy development, helping you navigate complex FDA regulations with ease. Our team provides expert guidance on clinical trial design and execution, ensuring robust data collection and compliance. We also offer quality management system implementation and optimization to meet industry standards. Additionally, we assist with market access strategies, including reimbursement planning and stakeholder engagement, to accelerate your product's success in the competitive healthcare market. Partner with us for tailored solutions that drive innovation and growth. For more information contact us at info@rxdeviceconsulting.com
Services
Our mission is to provide comprehensive support that meets the specialized needs of your product through every step of the regulatory authorization process.
Strategy and Product Launch
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Defining your technology roadmap
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Implementing hardware and software prototypes
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Software V&V testing and human factors testing
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Risk management
Scaling Operations
Clinical Trial Execution
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Defining a reimbursement strategy
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Identifying and vetting a CM to scale production and distributors to drive sales
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Setting up and maintaining an efficient Quality Management System (QMS), including providing audit support
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Identifying key clinical milestones
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Developing a clinical and product validation test plan
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Planning your regulatory strategy
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Preparation and submission of 510(k) applications to the FDA