Healthcare Device Manufacturing Security Program
Comprehensive security assessment for medical device manufacturers, covering FDA compliance, manufacturing processes, and device security throughout the development lifecycle.
In scope
- Manufacturing process security
- FDA compliance review
- Device firmware security
- Supply chain validation
- Quality control systems assessment
- Development lifecycle security
You receive
- Manufacturing security architecture
- FDA compliance documentation
- Security controls matrix
- Supply chain security framework
- Device security guidelines
- Secure SDLC implementation
Tiers
Choose the depth.
Core Manufacturing Security Assessment
$75K
Assessment for 1 device product line, 1 manufacturing site and up to 10 suppliers: manufacturing process security review, FDA cybersecurity requirements gap review, firmware security design review, quality system and development lifecycle review. Report and controls matrix.
- devices
- 1
- Sites
- 1
- vendors
- 10
- Manufacturing process security review of 1 site
- FDA cybersecurity requirements gap review
- Firmware security design review for 1 product line
- Supply chain review for up to 10 suppliers
- Security controls matrix and device security guidelines
- — Hands-on firmware or device penetration testing
- — Writing FDA submission documentation
- — Secure SDLC implementation
- — Additional product lines or sites
Advanced Manufacturing Security Program
$125K
Comprehensive program including detailed process validation and complete security implementation
- devices
- 3
- Sites
- 2
- vendors
- 25
- — Hands-on device penetration testing
- — Ongoing compliance management
- — Custom tooling
Enterprise Manufacturing Security Solution
$200K
Full-scope manufacturing security with custom tools, continuous monitoring, and complete compliance management
- devices
- 6
- Sites
- 5
- vendors
- 60
- — Hands-on device penetration testing (separate service)
- — FDA submission filing or regulatory representation
- — Tool licences and production hardware
Members: engagement coupons from the CISO Marketplace coupon book apply to services. There is no blanket discount.
What's inside this engagement
Phase by phase.
How a readiness & governance assessment engagement runs, what happens in each phase and what you see. Exact scope, tier and timeline are fixed in your proposal and SOW.
01Scoping & framework selection
The standard or regulation, the systems and the business units in scope are fixed.
You see · Your audit or regulatory driver.
02Evidence collection & interviews
Policies, configurations and records reviewed; control owners interviewed.
You see · Documents and time with control owners.
03Gap analysis
Each requirement mapped to current state: met, partial or missing, with the evidence behind it.
You see · A clear gap register.
04Roadmap & evidence plan
Prioritized remediation with owners, and the evidence an auditor will ask for.
You see · A plan you can execute or hand to us.
Commercials
From first call to final report.
- 01
Scoping call
A practitioner, not a salesperson, walks through targets, constraints and what a good outcome looks like for you.
- 02
Proposal & rules of engagement
A fixed-scope proposal with tier, price and deliverables. Rules of engagement, contacts and out-of-bounds systems are agreed in writing.
- 03
Sign, then start
MSA and SOW are signed electronically and the deposit is paid. Only then does testing begin.
- 04
Execution
Testing runs to the agreed plan. Critical findings are escalated as they are found; you don't wait for the report.
- 05
Report & debrief
An executive summary plus technical findings with evidence, reproduction steps and fixes, walked through with your team.
- 06
Retest
Where the tier includes it, we verify your fixes and reissue the report, so auditors and customers see the issues closed.
Timelines are set per engagement in the SOW.
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Research
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AI Device Code Phishing: The Auth Flow That Survives MFA, Password Resets, and Your SOC
Microsoft's Defender Security Research team documented a new AI-enabled phishing campaign leveraging the OAuth device code flow to compromise organizational accounts at scale. The EvilTokens toolkit automates code generation, bypasses the standard 15-minute expiration window, and leaves tokens that survive both MFA and password resets. Here's the technical breakdown and what to do about it.
ai-security · Apr 25, 2026
Healthcare Wasn't Ready for AI-Powered Attacks — and the Evidence Is Already In
A ransomware attack interrupted chemotherapy infusions at Brockton Hospital in April 2026. Spring Lake Park School shut down. A new generation of AI-accelerated attack tooling — including the capabilities unlocked by Project Glasswing — is compressing attack timelines in ways healthcare security programs weren't designed to handle. The gap is widening.
ai-security · Feb 25, 2026
Black Box in the Control Room: AI in Critical Infrastructure, Explainability Failures, and the Audit Gap CISOs Can't Ignore
AI is making life-or-death decisions in hospitals, power grids, and water treatment plants — and no one can explain how. The explainability crisis isn't academic. It's a compliance violation, a liability exposure, and a safety risk that regulators are about to enforce.
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