Medical Device Software Consulting
Medical device software (SaMD) engineering and advisory support for manufacturers, health systems, and digital therapeutics teams — working alongside your own regulatory and QA experts. We build software and organize documentation; we are not a regulatory authority.
Book a Strategy CallOur Medical Device Software Consulting Services
SaMD Software Engineering
We build Software as a Medical Device with your intended use in mind and help assemble the technical documentation your regulatory consultants need for classification and submission decisions. Regulatory strategy and any 510(k)/De Novo pathway are led by your qualified regulatory experts.
IEC 62304 Documentation Support
Software development lifecycle records and risk-management inputs organized to support IEC 62304-aligned processes. We coordinate with your QA/regulatory team; we do not issue certifications or QMS certification.
Cybersecurity Engineering Support
Threat modeling, SBOM generation, and post-market security monitoring engineering for connected devices, informed by published FDA cybersecurity guidance and reviewed with your security and regulatory advisors.
Digital Therapeutics Engineering
Product and platform engineering for prescription digital therapeutics (PDTs). Clinical evidence and reimbursement strategy are planned with your clinical, regulatory, and payer specialists.
BOOJEE Estate provides medical device software engineering and advisory support to health systems, digital health startups, and manufacturers. We combine software domain knowledge with modern tooling to help teams build and document their products, and we coordinate with the client's own regulatory, QA, and security experts on standards such as HIPAA and HL7. We do not clear devices, issue certifications, or act as a regulatory authority — regulatory clearance and compliance remain the client's responsibility, guided by their qualified experts. Every engagement starts with an honest technology audit — no vaporware, only clear scope.
Ready to Modernize Your Health Tech Stack?
Fixed-scope engagements built to ship. Architecture designed to support your HIPAA and security requirements, in coordination with your compliance team.
Get Your Free Health Tech AuditDisclaimer: BOOJEE Estate is a software engineering and advisory provider. We are not an FDA-cleared or FDA-registered medical device manufacturer, a regulatory authority, or a certifying body. We do not clear, approve, or guarantee regulatory approval of any device (including 510(k), De Novo, or PMA outcomes) and we do not issue HIPAA, IEC 62304, or ISO 13485 certifications. Regulatory clearance, quality-system certification, and compliance are the client's responsibility and should be directed by the client's qualified regulatory, quality, clinical, and legal experts. Nothing on this page is regulatory, clinical, or legal advice.