We are an engineering collective dedicated to empowering organizations in the medical device industry.
Our team consists of seasoned professionals with diverse expertise in product development, process development, regulatory affairs, quality assurance, and human factors engineering.
Together
Our Mission
We aim to provide innovative solutions that enable startups to navigate the complexities of bringing medical devices to market efficiently and successfully.
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By fostering a collaborative environment and leveraging our industry connections, we aim to become the go-to partner for emerging medical technology innovators.
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Our extensive industry knowledge and experience enable us to provide valuable insights and guidance, ensuring that our clients stay ahead in a rapidly evolving market.
Our Capabilities
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Design for Excellence (DFx)
Strategies for Design for Manufacturing and Assembly to optimize scalability and reduce costs.
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New Product Development
Comprehensive support in developing functional prototypes, design verification (DV), design verification testing (DVT), and batch releases to ensure innovative ideas become viable products.
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Quality Assurance
Implementation of a Quality Management System (QMS) tailored for startups, including internal audits and corrective action processes.
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Human Factors Engineering
Usability testing and design focused on enhancing product acceptance and safety.
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Regulatory Affairs
Expert guidance on 510(k) and PMA submissions, compliance audits, and risk management strategies.
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Clinical Trial Support
Assistance with protocol development, site selection, and data management for successful clinical trials.
Our Experience
With our extensive industry experience, a diverse cross-functional team, and a strong commitment to patient outcomes, we are uniquely positioned to support your mission of enhancing patient care effectively and efficiently.