We Help You Succeed
Over the years Bioscience has submitted thousands of pages of software engineering, V&V, and risk management documentation to FDA without any rejections, refusals or failures. Innovating is an essential part of a medical device startup, however insufficient software documentation to support the substantially equivalent claims to a predicate (510k) may cause early termination or closure for startups. Bioscience Pro prevents these failures.
Sample Projects Completed
3D CT, MRI image processing system, and DICOM upload System - Requirements Analysis and Identification, Architecture and Design, Full Test Protocol Development, Hazards Analysis. Performance Testing.
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Personal Wellness Tracking System - Requirements Analysis and Identification, Architecture and Design, Full Test Protocol Development, Hazards Analysis. Performance Testing.
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Personal Glucose Tracking and Management System - Requirements Analysis and Identification, Architecture and Design, Full Test Protocol Development, Hazards Analysis. Performance Testing.
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Breast Tumor Diagnostics System - Requirements Analysis and Identification, Architecture and Design, Full Test Protocol Development, Hazards Analysis. Performance Testing. Two successful submissions to FDA with two clearances.
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Proton Therapy System - Requirements Analysis and Identification, Architecture, and Design.
Often startups rush into a 510(k) submission to attract investors. With its vast experience in medical device software development processes, quality systems, and experience in 510(k) submissions, Bioscience Pro provides due diligence services to help Investors understand the actual status of a startup.
