We build test infrastructure with traceability, evidence, and review-readiness from day one, without adding unnecessary bureaucracy.
Validation for tools that sit inside your quality system, including lab databases, analysis code, automation frameworks, and COTS software used for regulated work.
Electronic records, audit trails, and reporting designed for trustworthy data and inspection readiness where Part 11 expectations apply.
Electromechanical devices, active implants, and energy-delivering systems demand predictable behavior, clear fail states, and repeatable measurement.
Robotic and motion-controlled fixtures for repeatable testing of mechanisms, charging, alignment-sensitive measurements, and cycle testing.
Gauge R&R, measurement uncertainty analysis, and calibration traceability to ensure test results are credible, comparable, and useful over time.
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Architecture decisions interact with quality system expectations (FDA 21 CFR Part 820 frameworks and ISO 13485-aligned practices), so traceability and evidence have to be designed in.
LMS, MES, lab tools, and analysis scripts can all end up in front of auditors. We apply validation proportionally and defensibly, based on risk and intended use.
Whether it’s an implantable system, an electromechanical instrument, or a diagnostic algorithm, we focus on predictable behavior, clear failure modes, and well-defined operating envelopes.
We build safety-critical test sets, embedded controls, and the software around them, then deliver the documentation and validation your team needs to run it, trust it, and maintain it.
Program Support
Join your team on a focused electromechanical device, implant program, SaMD platform, or automation effort where testing is on the critical path.
Modernize And Validate
Replace ad hoc tools with engineered test sets and defensible validation packages that your quality system can support.
Train And Transfer
Workshops plus implementation, with documentation and handoff so your team can sustain the system without us if that’s the goal.
We build safety-critical test sets, embedded controls, and the software around them, then deliver the documentation and validation your team needs to run it, trust it, and maintain it.
Discover the advantages of using CollabChat AI for your team collaboration needs.
If you’re staring at legacy test sets, unvalidated tools, or a looming CAPA and wondering how to get from “works in the lab” to “defensible in review,” we can help. Tell us what you build, where testing is hurting, and what your quality system expects.
