SERVICES

We provide a wide array of services that include early concept feasibility studies and systems engineering analysis through to the development of production-ready prototypes, clinical units for FDA (510)k approval.

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As a leader in the development IVD and point-of-care diagnostic instruments, Fusion provides a wide array of services that include early concept feasibility studies and systems engineering analysis through to the development of production-ready prototypes and clinical units for FDA 510(k) approval.

Fusion Biotec brings together art, science and engineering to create world class medical devices. We provide best practice processes in the medical industry to the designs that will drive your commercial success,

 

The founders have many years of experience providing medical device development services and have come together to redefine how projects are conceived and commercialized.

At Fusion Biotec, we celebrate the fusion of art science, engineering, and the creative process involved in conceiving and commercializing medical products. We are experts in developing complex analytical instrumentation for molecular and immuno-diagnostic markets. We’ve helped numerous clients with their FDA technical files. We also provide intellectual property and marketing assessment, usability engineering, regulatory planning, and compliance testing. With our knowledge of the device industry, we can provide contract manufacturing evaluations, recommendations, and transfer support to best fit the needs of your product.

Using state-of-the-art tools, we provide:

  • Highly-qualified engineering teams

  • Leverage for open-source software and hardware as well as platform technologies

  • Transparent and agile design processes

  • Tightly manages project schedules

  • Internal systems high in efficiency designed to control scope creep

  • Integrated Client processes for project control and authorization

  • Expert pool of Regulatory, Compliance and Marketing professionals

  • Mechanical, Electrical, Software and Usability Engineering  

  • Industrial Design  

  • Systems Engineering 

  • Value Engineering  

  • Optics Design (Fluorescence detection, cameras, etc.)

  • Usability (Human Factors) Engineering  

  • Market and IP Assessment

  • Regulatory Assessment and Planning

  • Compliance Assessment and Testing

  • Complete FDA ready design packages

  • Disposables Engineering

  • Prototype and Clinical Unit Assembly and Test

  • Contract Manufacturing Assessment and Recommendation

  • Transfer to Manufacturing Support

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Other Services

Fusion Biotec provides more than just engineering outsourcing and support.  Depending on the client’s needs, we also provide systems engineering, design control processes, EMI design and testing, clinical units for system verification and assistance in development of your technical file for FDA submission. 

 

In addition, we have a wide range of talented consultants that provide specific medical device expertise.  Our consultants have experience in medical device and in-vitro diagnostics marketing and communication, FDA and UL regulatory planning and execution, medical device reimbursement assessment and strategies, compliance testing and certification, and medical affairs.