Test systems for medical device programs where validation isn't optional.
Medical device manufacturing operates in regulated environments where test systems are more than a production tool; they're part of the validation record. ARC designs and builds medical device test systems engineered to meet the precision, documentation, and compliance requirements your program demands.
MODERNIZING COMPLEX PROGRAMS
Validation-ready test systems for regulated manufacturing environments.
Medical device test systems carry weight beyond the production line. They're part of the validation record, and regulators will scrutinize them accordingly. ARC builds to that standard.
| IQ/OQ/PQ | Installation, operational, and performance qualification built into test system design and delivery |
| V&V | Verification and validation support for medical device test systems |
| Safety | Test systems engineered to medical device safety standards |
| Validation Assistance | Support through your validation process, from protocol development through execution |
| Complete Traceability | Full traceability built into test systems to support your validation record |
| Compliance Matrix | Documentation mapping test coverage to regulatory and validation requirements |
| Regulatory Documentation | Documentation packages built to support regulatory submissions |
| MES Integration | Test system integration with manufacturing execution systems for production-level data capture |
| Highly Regulated & Compliance Processes | Engineering and quality processes built for FDA-regulated manufacturing environments |
| FDA-Compliant Test Systems | Engineered for FDA compliance and validation requirements |
| Healthcare Electronics Test Integration | Across diagnostics, imaging, and device categories |
| Lifecycle Support | From prototype validation through full production and sustainment |
Technical experience to solve any program challenge.
Test Systems
Replacement Parts & Contract Manufacturing
MODERNIZING COMPLEX PROGRAMS
In medical device manufacturing for your test system is your regulatory record.
Medical device programs operate under scrutiny that most industries don't face. Test systems have to produce consistent, repeatable, and documented results. The regulatory record demands it, and ARC builds to that standard.
Arc Pillars
Our Solutions
Why Medical & Healthcare programs
choose ARC.
Time to Market
Test system delivery that keeps pace with vehicle program timelines, whether you're sustaining a long-running line or launching something new.
Technical Depth
Electrical, mechanical, software, and RF engineering under one roof, with in-house contract manufacturing, so design and build stay under one team instead of splitting across vendors.
Supply Chain Management
We manage component sourcing and obsolescence so schedule risk doesn't slow your infrastructure rollout.
Design & Build Skills
From first article to full-scale deployment, ARC designs and builds in-house, with the flexibility to support both new architectures and existing infrastructure.
Flexibility
Whether your program needs a turnkey system, a single subassembly upgrade, or sustainment support on hardware with no documentation, we scope to what you actually need.
Dedicated Program Management
A single point of contact who knows your program, tracks risk, and communicates proactively — not just at milestones.
Robust
Quality ISO 9001 certified quality processes on every engagement, with the reliable test data your quality and throughput requirements depend on.
Strategic Partners
We work side-by-side with partners like NI and Keysight, tapping their equipment and top engineering talent to solve even the toughest test and RF challenges.
Trusted by medical device programs that can't afford validation gaps.
ARC delivers custom test systems for medical device manufacturers operating in regulated environments, engineered for the precision, repeatability, and compliance documentation that medical programs require, from initial prototype validation through long-term production sustainment.
The right medical device test system partner means fewer audit findings, faster clearance, and production that doesn’t stall.
ARC brings the engineering precision and compliance fluency to build test systems that perform in production and hold up under regulatory scrutiny. Let's talk about your validation requirements.
