C6 Systems
C6 Systems is an Irvine, California-based engineering services firm founded in 1993 that provides senior-level consulting and training for FDA-regulated medical device software development, serving Class I, II, and III device manufacturers.
- Company typePrivate
- Founded1993
- HeadquartersIrvine, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What C6 Systems does
C6 Systems is a privately held engineering services firm founded in 1993 and headquartered in Irvine, California, with a headcount in the 11-50 employee band. The company provides senior engineering services and training for FDA-regulated software development in the biomedical sector, specializing in supporting companies developing Class I, II, and III medical devices subject to FDA oversight. Its core offering combines deep technical engineering expertise with regulatory compliance knowledge spanning quality management systems, design controls, and regulatory submission processes.
The firm's value proposition is built on domain expertise in navigating FDA regulatory requirements and medical device quality standards, monetized through project-based consulting and training engagements rather than a proprietary software product. No specific pricing model, customer logos, marketing channels, distribution strategy, partnerships, certifications, patents, or awards are publicly disclosed in the available source material. The company operates with a vertical-focused go-to-market targeting FDA-regulated medical device developers exclusively.
C6 Systems has maintained continuous operations for over three decades, suggesting a stable, relationship-driven boutique consultancy serving a specialized regulatory niche. Public visibility is limited: no social media profiles, no management team disclosed, no funding rounds reported, no M&A activity, and no financial information available. This opacity constrains outside assessment of current scale, customer mix, and forward trajectory, though the deliberate small size and longevity point to a steady-state professional services model rather than a venture-backed growth bet.
C6 Systems firmographics
Firmographics- Name
- C6 Systems
- Legal name
- C6 Systems
- Website
- https://c6systems.com
- Company type
- Private
- Founded year
- 1993
- Headcount range
- 11–50 employees
- Short description
- C6 Systems is an Irvine, California-based engineering services firm founded in 1993 that provides senior-level consulting and training for FDA-regulated medical device software development, serving Class I, II, and III device manufacturers.
- Ownership category
- akta.pro rank
C6 Systems industry classification
Industry- Product category
- Medical Device Engineering Services
- NAICS
- Custom Computer Programming Services (541511), Scientific Research and Development Services (5417)
- akta.pro primary industry
- Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)
- akta.pro secondary industry
- Healthcare & Life Sciences (EDAAAPAA)
Keywords
Where C6 Systems is headquartered
LocationHeadquarters
- HQ city
- Irvine
- HQ country
- United States
- HQ region
- North America
Markets served
C6 Systems business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales
C6 Systems product offering
Product offeringCore offering
C6 Systems provides senior engineering services and training for regulated software development in the biomedical sector. The firm focuses specifically on FDA-regulated medical devices, offering experienced engineering talent and domain expertise to companies developing Class I, II, and III medical devices that must comply with FDA design controls, quality management systems, and regulatory submission requirements.
Product overview
C6 Systems provides senior engineering services for FDA-regulated medical devices, offering specialized expertise in medical device development and regulatory compliance.
Differentiator
Problem solved
Functional benefit
Products and services
- Senior Engineering Services for FDA-Regulated Medical Devices
Companies that use C6 Systems
Customer profileSegments1 record
Ideal customer profiles1 record
C6 Systems technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
C6 Systems competitors and assessment
Company assessmentBroad incumbents
- Underwriters Laboratories (UL): Safety science organization offering medical device testing, certification, and regulatory advisory services. Competes for regulated-services engagements with medtech manufacturers.
- MasterControl: Provider of quality and compliance software solutions for life sciences manufacturers, including medical device QMS. Offers services and consulting adjacent to C6's regulated-software focus.
- Intertek: Global quality assurance and testing company with a healthcare and medical device practice covering regulatory submissions, quality systems, and product safety. Operates in adjacent regulatory services territory to C6.
- IQVIA: Large global CRO and life sciences services firm with a medical device and regulatory affairs practice. Provides full-stack services that compete with boutique firms like C6 on scope, though at larger deal sizes.
- TÜV SÜD: International testing, inspection, and certification organization with a substantial medical device regulatory services practice. Offers overlapping FDA- and EU-focused compliance support to medtech clients.
- BSI Group: Global standards and certification body operating notified body services for medical devices, including quality management system audits and regulatory support. Competes for regulatory/compliance services adjacent to C6's offerings.
Others
- Veeva Systems: Cloud software and services provider for life sciences with quality/regulatory offerings (Veeva Vault). Enables the same FDA-compliance workflows C6 services, positioning it as an indirect technology competitor.
Direct peers
- NAMSA: The largest medical device-focused CRO/CDMO, providing regulatory, quality, and testing services to medtech developers. Most directly comparable to C6's FDA-regulated engineering services for medical device companies.
- RQM+: Medical device regulatory and quality consulting firm offering outsourced services in design controls, clinical evaluation, and submissions. Directly competes for the same type of FDA-compliance engineering work C6 performs.
Emerging players
- Greenlight Guru: Purpose-built QMS and quality management software platform for medical device companies. Adjacent rather than directly competitive, but increasingly bundles compliance services that overlap with boutique consultancies like C6.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks5 records
Key highlights5 records
Customer concentration
C6 Systems social profiles
Digital presenceC6 Systems financial estimates
Financial estimateRevenue estimate
Valuation estimate
C6 Systems leadership team
Management profileNumber of profiles
C6 Systems funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
C6 Systems M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about C6 Systems
What does C6 Systems do?
C6 Systems provides senior engineering services and training for regulated software development in the biomedical sector. The firm focuses specifically on FDA-regulated medical devices, offering experienced engineering talent and domain expertise to companies developing Class I, II, and III medical devices that must comply with FDA design controls, quality management systems, and regulatory submission requirements.
When was C6 Systems founded?
C6 Systems was founded in 1993. It employs 11 to 50 people.
Where is C6 Systems based?
C6 Systems is headquartered in Irvine, United States, in the North America region.
Who are C6 Systems's main competitors?
Broad incumbents on record are Underwriters Laboratories (UL), MasterControl, Intertek, IQVIA, TÜV SÜD and BSI Group. Veeva Systems is listed as an others. Direct peers are NAMSA and RQM+. Greenlight Guru is listed as an emerging player.
Does C6 Systems have an API?
No public API is recorded for C6 Systems.
What industry is C6 Systems in?
C6 Systems's product category is Medical Device Engineering Services. Its primary akta.pro industry code is HLAGAKAO, Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent), with a secondary code of EDAAAPAA, Healthcare & Life Sciences. Its NAICS code is 541511.