Medical device software (SaMD) strategy, FDA regulatory consulting, and digital health product development advisory for medical device manufacturers, health systems, and digital therapeutics companies.
Book a Strategy CallSoftware as a Medical Device (SaMD) classification, predicate device identification, and 510(k) or De Novo submission strategy tailored to your device and intended use.
Software development lifecycle documentation, risk management files, and quality management system setup aligned to IEC 62304 for FDA and CE mark submissions.
FDA cybersecurity guidance implementation — threat modeling, SBOM creation, vulnerability disclosure programs, and post-market security monitoring for connected devices.
Product strategy, clinical evidence generation planning, and reimbursement pathway advisory for prescription digital therapeutics (PDTs) seeking payer coverage.
BOOJEE Estate delivers medical device software consulting advisory to health systems, physician groups, digital health startups, and payer organizations. We combine deep clinical domain knowledge with modern AI tooling to help healthcare organizations improve outcomes, reduce costs, and meet HIPAA, HL7, and regulatory requirements without missing deadlines or blowing budgets. Every engagement starts with an honest technology audit — no vaporware, only outcomes.
Fixed-fee engagements built to ship. HIPAA-compliant architecture. Measurable clinical and operational outcomes.
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