"Your network isn't one network. It can't be."
R&D needs flexibility. Manufacturing needs validation. Corporate needs productivity. Guests need to not touch any of it. Most MSPs flatten this into a single VLAN and call it a network. We don't.
Industries → Medical Device Manufacturers
The IT partner your quality team trusts.
From the R&D bench to the manufacturing floor to the Part 11 audit trail — we manage the IT environment your FDA, ISO 13485, and EU MDR posture depends on.
We respect the validated state.
Nothing changes in a validated environment without change control. Period.
We engineer the segments.
R&D, manufacturing, corporate, guest — separated, monitored, documented.
We connect the stack.
QMS, ERP, PLM, MES, LIMS — talking to each other, with audit trails intact.
— Three Truths
Medical device IT isn't IT. It's a regulated discipline.
"21 CFR Part 11 doesn't care about your roadmap."
The audit trail has to be there. The electronic signature has to be enforced. The system has to be validated. We build IT around what Part 11, Part 820, and ISO 13485 require — not what's convenient.
"Your QMS is only as strong as the systems around it."
A perfect QMS doesn't help if it can't talk to ERP, if PLM is a separate silo, if the MES on the floor lives in its own world. We integrate the stack so the audit trail is continuous — not stitched together the night before the inspection.
— Who We Serve
From Class I to Class III. From R&D to commercial.
Early-Stage & R&D
Pre-510(k) startups building the systems they'll need at submission. We help you set up right the first time — so you're not retroactively validating an environment two years from now.
Commercial Manufacturers
Established device manufacturers running validated production. Multi-site operations. Real audit cadence. We keep the network, the systems, and the documentation in the posture Quality expects.
Contract Manufacturers (CMOs/CDMOs)
Multiple sponsors. Multiple QMS overlaps. Strict data isolation requirements per customer. We build the segmentation, access control, and audit trail your contracts require.
Combination Products & Connected Devices
Software-as-a-medical-device. Cybersecurity premarket submissions. SBOM management. Postmarket vulnerability response. We're fluent in the FDA cybersecurity guidance — and the operational reality behind it.
— The Differentiator
The network is the foundation of every claim you make to FDA.
A flat network can't enforce data integrity. A flat network can't isolate validated systems from corporate noise. A flat network can't survive an inspection. We design network architecture the way a quality engineer would — segmented, documented, and defensible.
Network Segmentation, Done Right
The architecture is the compliance foundation. We design and document:
- R&D network — fast, flexible, isolated from production
- Manufacturing network — validated, change-controlled, narrow
- Corporate network — productivity tools, M365, normal traffic
- Quality / regulated systems segment — QMS, eDHR, document control
- Guest / vendor network — fully isolated, with logging
- OT/IT boundary — clean room equipment and validated workstations on their own VLANs
- Documented network diagrams that survive an FDA inspection question
Validated Environments
We respect what 'validated' means. We work alongside your Quality team — not around them.
- Change control integration with your QMS workflow
- Documented IQ/OQ/PQ support for IT-managed systems
- Patch and update management with validation-impact assessment
- Separate environments: development, validation, production
- Audit trail preservation across infrastructure changes
- Disaster recovery plans that include re-validation pathways
System Interoperability
Your stack has to talk. Without breaking the audit trail.
- QMS ↔ ERP ↔ PLM ↔ MES ↔ LIMS integration architecture
- API and middleware support across Greenlight Guru, MasterControl, Veeva, ETQ, Arena, Windchill, SAP, NetSuite, Oracle
- eDHR continuity between PLM and MES
- Document control sync between QMS and engineering systems
- Single sign-on and access governance across the regulated stack
- Data integrity (ALCOA+) preserved at every integration point
In medical device manufacturing, the network is the quality system. We treat it that way.
Greenlight GuruMasterControlVeeva QualityOneETQAssurXQualioArenaWindchillPropelSAPNetSuiteOracleLabWareMicrosoft 365Azure
— Compliance, Built In
Part 11. Part 820. ISO 13485. EU MDR. We know the boxes — and what's actually inside them.
Compliance isn't documentation. It's the operational reality the documentation describes. We build the IT environment so what's written in your SOPs is what's actually happening on the network — every day, not just inspection week.
The gap between what your QMS says and what your IT environment does is where 483s come from. We close that gap — and keep it closed as the environment evolves.
What we deliver
- 21 CFR Part 11 — audit trails, electronic signatures, access controls, time stamps
- 21 CFR Part 820 / ISO 13485 alignment in IT-managed processes
- EU MDR & MDSAP readiness across IT infrastructure
- ALCOA+ data integrity controls at every integration point
- Cybersecurity premarket submissions — SBOM management, threat modeling, FDA guidance alignment
- Postmarket cybersecurity — vulnerability monitoring and coordinated disclosure support
- Change control that respects validated-state boundaries
- Tabletop drills for FDA inspection and cybersecurity incident response
- Documented evidence packages ready for auditors — not assembled the week before
— Our Five Services, Translated
Five services. Translated for medical device manufacturers.
Managed IT & Helpdesk
"A helpdesk that knows the difference between 'the validated system is slow' and 'the validated system is down.'"
Office, lab, and floor support.
Security & Compliance
"Audit-quiet by default. 483-free by design."
Part 11, Part 820, 13485, MDR, and FDA cybersecurity guidance — built into the environment, not bolted on.
Infrastructure & Cloud
"Networks segmented the way a quality engineer would design them."
Validated environments, OT/IT separation, M365, Azure with regulated-workload posture.
Strategic Advisory (vCIO/vCISO)
"We sit at the management review."
Roadmap and security leadership built around your submission pipeline and regulatory cadence.
AI & Vendor Advisory
"We tell you which eQMS is worth migrating to — and which one will burn six months of validation effort."
Honest evaluation. No vendor commissions.
— Results
Quiet. Documented. Inspection-ready.
We brought Kilik in six weeks before an MDSAP audit. They re-architected our network into proper segments, fixed the gaps between our QMS and ERP, and documented every change. The auditor's only comment was, 'This is the cleanest IT documentation we've seen this year.'
9
manufacturers supported through audit cycles
0
IT-related 483s across our client base
< 4 hours
average ticket response
Let's talk before your next audit.
Thirty minutes with someone who's been in a Part 11 conversation. We'll listen to where your environment stands, where the gaps are, and tell you straight whether we can help.
talk@kilik.net · 415-523-1400