Medical Device & Life Science Test Automation Built for regulated environments
Medical device testing isn't just about passing limits — it's about producing defensible data in a validated, traceable system. We build LabVIEW-based automated test solutions designed for the rigor, documentation, and regulatory scrutiny your quality system demands.
Cheap and Fast means audit failures
In the race to market it can be tempting to pick the fastest, cheapest option. But when it comes time for clinical trials or audits, it is the rigor and discipline behind your test systems that will ensure you are meeting the quality standards you truly demand.
Common Failure Modes
- A test system, but not a life sciences test system
- No traceability to test specifications — results can't be linked back to device requirements or risk controls
- Hardcoded acceptance limits — updating pass/fail criteria requires a software change order and full revalidation
- Opaque validation packages - IQ/OQ/PQ documentation is sparse, ad-hoc, or missing entirely
- Instrument coupling — a discontinued DMM or oscilloscope model forces a complete software rewrite
- Single-developer knowledge — the engineer who built it left, and no one understands it now
The CMC Approach
- Alignment with 21 CFR Part 11
- Requirements traceability matrix (RTM) linking every test step to a requirement or risk control
- Configuration-driven limits — update acceptance criteria in a controlled data file, not in source code
- Structured IQ/OQ/PQ validation package delivered alongside the software
- Instrument abstraction layer and noncoupled approach — swap hardware or functional modules without touching validated test sequences
- Built to architectural standards for easy reference and transfer
Full-spectrum medical device test automation Designed for Quality Systems
From bench-level R&D fixtures to production-floor functional testers, we engineer systems that generate defensible data, can survive regulatory audits, and adapt as your device evolves through its lifecycle.
End-of-line functional test systems
Production test stations for medical devices — automated go/no-go functional testing, operator guidance, and LIMS-ready data output.
Validation-Ready Test Software
Computer System Validation (CSV) packages including IQ/OQ/PQ protocols, traceability matrices, risk assessments, and change control as required.
Sensor Calibration Automation
Automated calibration and verification workflows for pressure, temperature, and electrical sensors used in instruments and monitoring equipment.
Data Acquisition & Signal Analysis
High-speed, multi-channel DAQ for physiological signals — synchronized with device state and time-stamped for traceability.
Operator & Researcher Interfaces
Custom UIs designed for actual lab workflows. Live visualization, guided step-by-step instructions, controlled access.
Legacy System Migration & Remediation
Systems on Windows XP/10 or obsolete instruments can create compliance risk. We migrate and re-validate them without losing the core functionality.
An engagement built on trust
We don't process transactions. We partner. Here's what a typical test system engagement looks like — from first call to production readiness.
Choose Movement
Our Choose Movement philosophy shapes everything we build. We design great systems and software, but it is the way we work that truly sets us apart. We aim to be straightforward, flexible, and understanding in our approach. We do not shy away from tough conversations and come prepared with solutions. We are honest in our communication and hope to receive the same from you.
Outsourcing that survives the audit
Medical device teams have been burned by vendors who cut corners or built something that worked on day one but crumbled the moment a test requirement changed. It doesn't have to be that way.
Let's talk about test
Whether you have a full test specification or just a prototype, we'll help you figure out the right architecture and validation strategy - for where you device is today and where it is going.