Services
Engagement
Success stories
Capability
Insights
Contact
Book a call
Security · Privacy · Technology

We don't just review AI.
We build it — then govern it.

Most advisors stop at assessing someone else's systems. BitSense designs, ships, and governs them. Writing the retrieval pipeline and writing the model-risk policy is what makes guardrails practical instead of theoretical.

Medical devicesDefense supply chainConnected productsCloud platformsBig-data systems
How we work together

Four ways to engage

Scoped to your stage — from a single assessment against a deadline to embedded leadership.

Retainer

Fractional CISO

Ongoing embedded security, privacy, and technology leadership without a full-time hire.

Fixed scope

Project-Based

Gap assessments, audit readiness, threat models, and architecture reviews against a date.

Delivery

AI Build & Prototype

Working GenAI and agentic systems — designed, built, and delivered. Not slideware.

Executive

Board Advisory

Board briefings, AI strategy, and on-demand guidance for investment and risk decisions.

Capabilities

Eight practice areas

Open any area for scope and the standards it maps to.

AI-ENGAI, GenAI & Agentic Engineering
Design and delivery of RAG pipelines, agentic workflows, and LLM-assisted tooling — with deterministic cores, human approval gates, and evaluation harnesses built in. Scores and control decisions never derive from model output: models draft narrative, code decides outcomes.
RAGAgentic workflowsTool use / MCPVector searchModel evaluation
AI-GOVAI Security & Governance
Secure AI in regulated settings — AI inventory and use-case register, tiered risk classification, agentic identity and least privilege, prompt-injection and exfiltration defense, and AI in third-party risk.
NIST AI RMFISO/IEC 42001EU AI ActOWASP LLM Top 10OWASP Agentic Top 10MITRE ATLAS
CMP-REGCompliance & Regulatory Alignment
Readiness mapped to shared controls so one body of evidence serves several frameworks instead of duplicating effort across audits.
FDA §524BEU CRAISO 14971IEC 62443NIST SSDFSOC 2HIPAAGDPR
PRD-SECProduct & Device Security
Secure SDLC, threat modeling, SBOM and VEX, premarket and postmarket cybersecurity, and stand-up of PSIRT and coordinated vulnerability disclosure programs.
Secure SDLCThreat modelingSBOM / VEXPSIRTCVD
CLD-SECEnterprise & Cloud Security
Cloud security architecture on AWS — posture and workload protection, entitlement management, identity, encryption, and security operations from design through hardening.
AWSCSPMCWPPCIEMIAMZero Trust
ASM-MATGap & Maturity Assessments
Benchmarking with prioritized, cost-aware remediation roadmaps — findings ordered by risk reduction per dollar, not by control number.
NIST CSFCMMC L1/L2ISO 27001SOC 2
PRV-ENGPrivacy Engineering
Data mapping, DPIAs, minimization, retention, and data-boundary design for LLM and analytics workloads — including zero-egress architectures where data cannot leave the client.
GDPRHIPAADPIAData boundaryOn-device inference
EXE-RSKBoard & Executive Risk
FAIR-based quantitative risk and financial-exposure modeling that translates technical and AI risk into dollars and decisions a board can act on.
FAIRQuantitative riskBoard reporting
Success stories

What the work actually changed

Engagements are described by sector and problem shape rather than by client name.

Before publishing: outcome figures marked [ metric ] must come from your own records. Replace each with a number you can evidence, or delete that outcome strip. Confirm client consent and NDA position for every story, then delete this note.

01

Premarket cybersecurity evidence for an infusion platform under regulatory hold

Medical device

Challenge

A connected infusion platform was held at FDA under Regulatory Hold. Cybersecurity documentation had to satisfy reviewer scrutiny at the highest level, against a clearance timeline the business could not afford to miss.

Approach

Rebuilt the premarket package around ISO 14971 risk linkage — threat model, SBOM, vulnerability handling, and postmarket surveillance commitments traced back to specific hazards rather than presented as a control list.

Outcome

510(k) clearance obtained. The evidence structure became the template for subsequent submissions across the product family.

510(k)
Clearance achieved under Regulatory Hold
[ metric ]
Review cycles to clearance
02

Coordinated disclosure stood up from zero to first published advisory

Connected products

Challenge

A product organisation had no route for external researchers to report vulnerabilities. Reports arrived through sales contacts and personal inboxes, with no triage, no severity discipline, and no publication path.

Approach

Designed and built a fifteen-stage intake-to-publication pipeline with five named human approval gates, deterministic CVSS-based severity scoring, and LLM-drafted advisory narrative only — never scoring. Added a Trust Center and notification outbox.

Outcome

A defensible disclosure programme with a full audit trail on every decision: inputs, tool calls, and the approver who released it.

15 stages
Intake to publication, fully logged
5 gates
Named human approvals before release
[ metric ]
Median time to advisory
03

One evidence set carried across four compliance frameworks

SaaS & cloud

Challenge

A small team was rebuilding the same evidence separately for SOC 2, HIPAA, GDPR, and cloud hardening reviews. Audit preparation consumed engineering capacity every quarter and findings repeated year over year.

Approach

Mapped 47 SOC 2 controls and 28 common-framework controls to a single shared-control library with HIPAA and GDPR overlays, plus AWS, Azure, and GCP hardening checklists. Delivered as an operable platform with an executive risk dashboard rather than a spreadsheet.

Outcome

Evidence collected once and reused across frameworks, with control ownership and status visible to leadership between audits instead of only during them.

75 controls
SOC 2 and common framework, unified
4 frameworks
Served by one evidence set
[ metric ]
Reduction in audit prep effort
04

Document AI delivered with zero data egress

Regulated data

Challenge

An automation opportunity involved sensitive documents that could not be sent to a third-party model provider under the organisation's data-boundary commitments. Conventional cloud AI was not available as an option.

Approach

Built entirely client-side: in-browser OCR with a Tesseract and WebGPU vision-model cascade across 18+ content types, a fully deterministic evaluation engine, negative-test generation, and per-item fault isolation so one bad input degrades one unit of work rather than the batch.

Outcome

Automation delivered with no data leaving the client environment and no CDN dependency — removing the vendor data-use question from the approval path entirely.

Zero egress
No data leaves the browser
18+ types
Content classes handled
[ metric ]
Throughput per batch
05

Security strategy made legible to a board

Executive advisory

Challenge

Security investment decisions were being made from a control-maturity heatmap that told directors what was red but not what it would cost them, or what spending would change.

Approach

Introduced FAIR-based quantitative loss modelling alongside a strategy desk tracking pillars, weekly progress, meeting records, and stakeholder communications — with Word and Excel export shaped for the board pack.

Outcome

Risk discussion moved from colour-coded severity to expected annual loss and marginal risk reduction per dollar, which changed the order of the roadmap.

FAIR
Quantified exposure in dollars
[ metric ]
Programme spend reprioritised
Insights

Writing from the build side

Notes on AI governance, compliance strategy, and product security — from a practice shipping the systems, not just reviewing them.

Representative work

Systems built and shipped

CVD Pipeline

Coordinated Vulnerability Disclosure

Fifteen-stage intake-to-publication workflow with five human approval gates, deterministic severity scoring, LLM-generated advisory narrative only, an integrated Trust Center, and a notification outbox.

Platform

Compliance Program Platform

Single-file web application covering 47 SOC 2 controls and 28 common-control-framework controls, with HIPAA and GDPR overlays, AWS/Azure/GCP hardening checklists, and an executive risk dashboard.

Engine

Deterministic Engine with In-Browser OCR

Client-side document processing across 18+ content types using a Tesseract and WebGPU vision-model cascade, with a fully deterministic evaluation engine, negative-test generation, and per-item fault isolation. Zero data egress.

Executive tool

Security Strategy Desk

Tracking for strategic pillars, weekly progress, meeting records, and stakeholder communications, with Word and Excel export for board reporting.

About

A practice that builds and governs

BitSense Consulting provides security, privacy, and technology leadership across big-data platforms, AI and generative AI, cloud infrastructure, hardware, and connected products. Board-ready strategy paired with in-the-details execution.

Twenty-five years of practice across regulated industry — medical devices, defense supply chain, and connected products — including FDA 510(k) clearance achieved for an infusion-platform program under Regulatory Hold.

Engagements are principal-delivered. The person who scopes the work delivers it.

Start a conversation Download capability statement
Contractor data

Procurement details

UEIenter
CAGEenter
SAM statusconfirm
Business sizeSmall
Primary NAICS541512
Additional541519 · 541611
Also541690 · 541715
PSCD310 · D307 · R408

Fill or delete before publishing. An unverified UEI or CAGE on a page soliciting federal or prime-contractor work is a real exposure.

Contact

Start a conversation

Tell us the deadline you're working against and the framework in play. We'll reply within one business day and tell you honestly whether we're the right fit.

Emailinfo@thebitsense.com Phone617-866-8642
LocationAshland, Massachusetts
Response timeWithin one business day

Form not connected yet. Create a free endpoint at formspree.io (or Web3Forms / FormSubmit), then paste it into FORM_ENDPOINT near the bottom of this file. Until you do, submitting opens a pre-filled email in the visitor's mail client. Delete this paragraph once live.

Enter your name so we know who we're replying to.
Enter a valid email address, like name@company.com.
A sentence or two about the problem is enough to start.
We use your details only to reply to this enquiry.

Message sent

Thanks — we'll come back to you within one business day. If it's urgent, call 617-866-8642.

That didn't send

The form couldn't reach the server. Try again, or email info@thebitsense.com directly.