Enterprise AI · GRC · OT Cybersecurity
AI-accelerated GRC for the systems that run your plant.
GRC for OT and connected products — AI-accelerated, audit-ready, and mapped to IEC 62443, EU CRA, NIS2, and ISO 27001. Consulting, testing, and security leadership on demand.
Talk to an ExpertExplore Services
- 2010
- Established
- Fortune 50
- Client Experience
- IEC 62443
- Standards Committee Members
- Global
- Clients · US & EU Regulation
- 100%
- Independent & Family-Run
Standards we work in
- IEC 62443
- EU CRA
- NIS2
- ISO/IEC 27001
- IEC 81001-5-1
- MDS²
- SOC 2
- ISO/IEC 42001 (AI)
Why Malkan Solutions
Trusted with critical systems since 2010.
Privately held, independent, family-run. No outside investors, no quarterly pressure. Our name is on the work.
Senior people on every engagement
The experts doing the work. No hand-offs, no bait-and-switch staffing.
Independent & unconflicted
No tool resale, no vendor commissions. Our advice serves one interest: yours.
Long-term partners, not a transaction
Clients in medical devices, automation, and automotive stay with us for years.
Industries
Built for regulated, engineering-driven manufacturers.
Where security failures have physical consequences — and the bar is rising fastest.
Medical Devices
Secure development lifecycles, hospital security questionnaires, and submissions support for connected health products.
Industrial Automation
OT security programs, plant-floor architecture review, and product security for control systems and connected equipment.
Automotive
Embedded device security, supplier security requirements, and compliance alignment across global automotive supply chains.
Why Malkan Solutions
Platforms automate. Big firms staff up. We build your capability.
Where we sit against the usual alternatives manufacturers consider.
Swipe the table to see every column
| Big certification firms | Compliance platforms | Malkan Solutions | |
|---|---|---|---|
| Senior experts do the work | Leveraged junior teams | Software + support | Senior people on every engagement |
| Enterprise AI acceleration | Rarely | Automation only | AI speed with expert review |
| Builds your in-house team | Perpetual engagement | Platform dependency | Train, hand off, stay on call |
| Executive leadership (vCPSO) | Not offered | Not offered | Fractional CPSO on demand |
| OT + AI governance in one shop | Separate practices | Product scanning only | 62443 + CRA + ISO 42001 together |
| Independent & unconflicted | Cert + advisory conflicts | Vendor lock-in | Privately held, no resale |
FAQ
Common questions.
What manufacturers ask us most — before they become clients.
What does Enterprise AI governance mean for OT cybersecurity?
It means AI use is governed before it touches plant-floor context, product security data, customer evidence, or regulated documentation. We define access rules, model risk controls, human review gates, and source traceability so AI improves speed without weakening auditability or OT safety.
When do I need to comply with the EU Cyber Resilience Act?
Obligations are phased: vulnerability-reporting obligations apply from 11 September 2026, and full compliance is due 11 December 2027 for products with digital elements sold in the EU. Non-compliance risks fines and lost market access — a prioritized roadmap matters now.
What's a vCPSO, and how is it different from a vCISO?
A virtual Chief Product Security Officer leads security for the products you ship and the OT that builds them — IEC 62443, EU CRA, secure development lifecycle, supplier security. A vCISO is IT-focused: corporate networks, SOC 2, email. For connected-product makers, product security is its own discipline.
Will you replace our engineers or make us dependent on you?
The opposite. Discover, Define, Build, Enable: we stand up the processes, train your engineers, and hand the capability off. Success is what still runs after we leave.
Which standards and regulations do you cover?
IEC 62443 (incl. 4-1/4-2), EU CRA, NIS2, ISO/IEC 27001, ISO/IEC 42001 and the EU AI Act, IEC 81001-5-1 and MDS² for healthcare, and SOC 2. We sit on IEC OT cybersecurity standards committees — we work from the source.
How fast can you stand up a GRC capability?
A gap assessment and report-out lands in weeks. A documented GRC operating model with trained staff follows over a few months, depending on scope. AI acceleration compresses the document-heavy phases.