Full-Service FDA Premarket Cybersecurity for Wearables & RPM
End-to-end FDA premarket cybersecurity for medical wearables and remote-patient-monitoring - BLE, mobile, cloud, and 524B-aligned eSTAR documentation.
Aligned to FDA's February 3, 2026 premarket cybersecurity guidance.
Wearables and RPM devices look simple - sensor, BLE, phone, cloud - but the premarket cybersecurity package is anything but, because the device is mostly software living on a phone you don't control and a cloud you operate. Our full-service premarket package for this segment treats the system as the wearable + the mobile app + the cloud + the clinician portal, and builds the SPDF, threat model, SBOM, pen testing, and architecture views to span all four.
The threat model assumes the mobile app is compromised by default - because for a consumer device that's a realistic baseline - and forces the question of which controls actually live on the wearable vs. the phone. We've found that most wearable submissions over-trust the phone; our threat model pushes the integrity-critical controls back onto the wearable. The SBOM covers the wearable firmware, the mobile-app dependencies (more numerous than teams realize), and the cloud backend. Pen testing exercises BLE pairing, the device-to-cloud path through a compromised phone, and the clinician portal for IDOR and cross-tenant leakage. Security architecture views include the multi-patient harm view explicitly, because RPM is a multi-patient cloud architecture by definition. Package is eSTAR-ready and aligned to 524B + the 2026 final guidance.
Layers we exercise in this engagement
The wearables / rpm system, from the outermost cloud and clinician surfaces down to the device itself. Highlighted layers are exercised by this fda premarket cybersecurity package.
- 01Clinician portal
- 02Cloud APIs Tested
- 03Mobile companion app Tested
- 04BLE telemetry Tested
- 05Wearable firmware Tested
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
FDA Premarket Cybersecurity Package engagement, end to end
Four phases, fixed fee, scoped to wearables / rpm architecture from kickoff onward.
- 01
Submission gap check
Existing artifacts mapped against Section 524B(b) and the Feb 2026 guidance; gaps flagged in one document.
- 02
Artifact production
Threat model, SBOM + VEX, SPDF, architecture views, cybersecurity risk assessment, and labeling produced or upgraded as needed.
- 03
Pen test + evidence
Independent pen test executed and findings closed before lock so the report ships clean inside the submission.
- 04
eSTAR-ready handoff
Every artifact delivered in the eSTAR attachment format; we stay on call through the review cycle.
What we see in Wearables / RPM fda premarket cybersecurity package
The patterns we hit in this segment, this service, again and again.
Wearable integrity controls delegated to mobile app
App enforces sample validity, device authenticity. Reviewer asks 'and if the app is compromised?' - gap on file.
Multi-patient harm view not provided
Architecture view shows single-patient flow only. Cloud serves thousands; multi-patient view is a 524B explicit deliverable.
Mobile-app SBOM absent
Firmware SBOM only. Mobile-app SBOM expected for any submission where the app is part of the indications for use.
Clinician portal not pen-tested
Pen test scope was wearable + BLE only. Cloud and clinician portal excluded; reviewer asks why.
"Blue Goat Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience."
Standard FDA Premarket Cybersecurity Package deliverables
The same deliverables the parent FDA Premarket Cybersecurity Package service ships with - tuned to your wearables / rpm architecture.
- Secure Product Development Framework (SPDF)
- SBOM generation and vulnerability triage
- Threat modeling aligned to ANSI/AAMI SW96 + ISO 14971
- eSTAR-ready cybersecurity documentation
What lands in your eSTAR submission
Documents structured for the cybersecurity attachments of your submission - no reformatting on your side.
- Secure Product Development Framework (SPDF)
- SBOM generation and vulnerability triage
- Threat modeling aligned to ANSI/AAMI SW96 + ISO 14971
- eSTAR-ready cybersecurity documentation
Standards that apply
The Wearables / RPM baseline, plus the call-outs that matter for fda premarket cybersecurity package in this segment.
Segment-specific call-outs
FDA 524B + 2026 final premarket guidance
RPM is the canonical multi-patient cloud architecture - multi-patient harm view is a hard deliverable.
ANSI/AAMI SW96
Threat-model rigor expectations for consumer-grade interfaces in a regulated context are anchored here.
What's not in scope
We scope tightly on purpose. These items are either out-of-scope by design or belong in a separate engagement - we'll tell you up front, not after kickoff.
- Quality system buildout (ISO 13485 / QMSR) - separate engagement
- Clinical or biocompatibility sections of the submission
- Regulatory filing on your behalf as agent of record
FDA Premarket Cybersecurity Package for Wearables / RPM - FAQs
The questions buyers in this segment actually ask before scoping a fda premarket cybersecurity package engagement.
Go deeper on Wearables / RPM and premarket
A practical, ungated buyer's guide for medical device manufacturers evaluating cybersecurity partners, what goes wrong, why it costs you, and what to demand from your next engagement. Aligned to the FDA February 2026 premarket guidance.
A practical, ungated guide to the threat modeling gaps that trigger FDA cybersecurity questions in 510(k), De Novo, and PMA submissions - and exactly how to close them before reviewers find them.
The most common cybersecurity deficiencies in 510(k), De Novo, and PMA submissions, what triggers each one and how to fix it before you file. Aligned to the FDA February 2026 final guidance and Section 524B.
Medical device cybersecurity should scale with device risk. Christian Espinosa argues why meeting only the Section 524B minimum leaves patients and submissions exposed.
VEX resources for medical device teams: a document guide, SBOM comparison, and common assessment mistakes, with evidence-based status and regulatory context.
Medical device cybersecurity for nanotech neurostimulation: a fictional STRIDE threat model linking controller risks, patient harms, controls, and testing.
Other engagements for Wearables / RPM
Teams in this segment commonly bundle these alongside fda premarket cybersecurity package.
Keep going
Scope a FDA Premarket Cybersecurity Package engagement for your wearables / rpm program.
A 30-minute discovery call with Christian Espinosa, Founder and CEO, and Kristy Kennedy, VP of Sales.