Submission is on the calendar - you have time to get it right
Pre-submission is when reviewers' future questions are answered or buried. Start ~9 months before your 510(k), De Novo, or PMA goes in so manual pen testing, the threat model, the SBOM, security architecture views, and the Section 524B narrative all land in eSTAR together - coherent, traceable, and reviewer-tested.
Hardware, firmware, mobile, and cloud - tested by operators with both red-team and medical-device experience. Reports built for FDA reviewers.
Explore service PremarketÀ la carte wireless interface testing for medical devices - BLE pairing, GATT enumeration, Wi-Fi association, NFC/RFID, and proprietary RF protocol fuzzing. Reviewer-ready evidence for FDA premarket and EU MDR submissions.
Explore service PremarketÀ la carte firmware testing for embedded medical devices - extraction via JTAG/SWD/UART or chip-off, binary analysis, secure boot validation, and OTA update path testing. Findings traceable to your SBOM and threat model.
Explore service PremarketÀ la carte cloud backend testing for connected medical devices - AWS/Azure/GCP infrastructure, device-to-cloud APIs, IAM and tenant isolation, PHI data flows, and HIPAA-aligned controls. Reviewer-ready for FDA submissions and SOC 2 evidence.
Explore serviceFree 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.
