We support device manufacturers across California, from early-stage innovators to established Class II and Class III companies. Most deal with some version of these issues:
Managed IT Services for Medical Device Manufacturers in California
Experience Matters. IT Solutions for Medical Device Manufacturing
Secure, compliant, and audit-ready IT for device makers across Irvine, Orange County, San Diego, Los Angeles, the Bay Area, and the rest of California.
Are These IT Challenges Slowing Down Your Medical Device Operation?
FDA compliance stress
Systems that aren’t aligned with design controls, validation, audit trails, or recordkeeping requirements.
Unreliable lab and production systems
Instrument PCs, calibration tools, and cleanroom systems that freeze at the wrong time, usually during testing.
QMS, PLM, or ERP downtime
When quality or engineering systems go down, design reviews, traceability, and documentation stop moving.
IP protection worries
Firmware, CAD files, algorithms, and clinical data that aren’t properly secured.
R&D and engineering bottlenecks
Slow networks, poor access control, unreliable VPNs, and lack of secure collaboration tools.
Vendor and supply-chain risk
Contract manufacturers and testing partners with weak cybersecurity practices.
Growing cybersecurity pressure
New FDA cybersecurity rules, ISO requirements, and cyber insurance demands that keep tightening.
Partner with Consilien for FDA-Ready, Reliable IT
We’ve supported manufacturers across California for more than 25 years. From Irvine’s major MedTech hub to R&D centers in San Diego and engineering labs in the Bay Area, we understand how regulated environments operate and what auditors expect.
What Sets Consilien Apart
- Deep experience with FDA-regulated environments
- IT support aligned with ISO 13485 and ISO 14971 practices
- Systems built to support design controls, documentation, and traceability
- IT and OT support for cleanrooms, labs, and test equipment
- Cybersecurity-first mindset to protect your IP and patient safety
- Infrastructure that scales with R&D, testing, and manufacturing
- Clear communication and practical solutions, not jargon
Our goal is simple. Keep your systems stable, secure, and audit-ready so you can move faster with confidence.
A Clear Path to Stable, Compliant IT
Most device manufacturers come to us because their systems feel fragile or siloed, or because compliance work is taking too much time. Our process gets everything under control.
1. Assess and Stabilize
We review your IT, labs, production systems, cloud, vendors, and cybersecurity posture, then fix the issues causing downtime or audit risk.
2. Secure IP and Protect Your Operation
Strong access control, encrypted data, secure R&D environments, vendor restrictions, and protections for designs, firmware, and test data.
3. Support FDA, ISO, and Validation Requirements
Audit-ready infrastructure, clean documentation trails, change control alignment, and systems that fit your QMS and validation processes.
4. Measure, Report, and Guide
Clear dashboards for uptime, compliance readiness, cyber posture, and long-term planning.
5. Modernize and Scale
Cloud tools, automation, secure collaboration, and data workflows that support faster NPI cycles, without disrupting testing or production.
Future-Ready IT for Medical Device Companies
Strong IT isn’t just about keeping the lights on. It’s the backbone of R&D, testing, manufacturing, and post-market support.
Our IT and Cybersecurity Services for Medical Device Manufacturers
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Serving California’s Medical Device Hubs
We support device makers across:
- Irvine and Orange County
- San Diego
- Los Angeles
- Silicon Valley and the Bay Area
- Ventura and Thousand Oaks
- Inland Empire And more!
Industries we support include:
- Class I, II, and III devices
- Diagnostics and instruments
- Wearables
- Robotics
- Implantables
- Connected and smart devices
If you design, test, or build medical devices in California, we’re built for you.
Build a Reliable, Compliant IT Foundation
If you’re tired of IT issues slowing R&D, threatening audits, or delaying production and growth, we’re here to help. Let’s build an IT environment that keeps your devices and your business moving forward.
Our Clients' Success
Frequently Asked Questions
How do you support FDA and ISO 13485 compliance?
We align IT systems with design controls, documentation needs, validation, audit trails, and data integrity principles.