Every new device this company brings to market needs a full FDA design-control file and a 510(k) submission. Its small R&D team wrote all of it by hand. Now a private Brain, running in the company's own Microsoft cloud, drafts each stage from the company's own templates and procedures.
Client names available upon request.
Bringing a device to market means a project plan, an initial risk analysis, design input requirements, validation protocols and reports for cleaning, packaging, performance, and sterilization, and finally the 510(k) summary. Each document follows the company's own procedures, templates, and numbering rules. Each one was written by hand, by a team that would rather be in the lab.
The work is repetitive in structure and unforgiving in detail. Getting a reference wrong, or missing a requirement that should trace through to a test, costs weeks.
Pulls public FDA data for the device: adverse-event reports, prior clearances and predicates, classifications and product codes.
Drafts the project plan and the design input requirements from the device documentation and the applicable standards.
Drafts the failure modes and effects analysis, one line item per process step, in the company's template.
Drafts validation protocols, then the reports, in the company's exact formats and numbering.
Traces every requirement through to its test, then assembles the submission package for review.
Every draft lands in a review queue. The R&D team edits, approves in sequence, and signs, exactly as before.
The regulatory file is built from device documentation, public FDA data, and the company's own standards, not patient records. The platform is designed to keep protected health information (PHI) out of scope.
HIPAA is a set of rules a company and its vendors follow, not a certificate. We build to it and sign a BAA wherever PHI is involved.
Each draft follows the company's own templates and procedures and is traceable to the sources it used. The team reviews and signs instead of starting from a blank page.
The R&D team starts each document from a draft built on its own approved files, so its time goes to judgment and testing rather than formatting and cross-references.
Because the code, cloud, and data are the company's, its own team can keep developing the platform. That is the point of owning it.
Customer, staff, product, and program details have been removed to protect the client's confidentiality. Client names available upon request.
In one strategy session we map where a Brain would return the most time, what we'd build first, and how we'd measure it from month one.
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