Test infrastructure and V&V across the full Class II and III implants and IVDs. Selected examples from our delivered work:
Production data acquisition, pump programming and test software, life cycle tester gap analyses, requirements traceability matrices, an automated PDF test report toolkit, a LabVIEW coding standard, and FDA warning letter remediation work.
CI/CD pipeline with build server and integrated help-file generation, FDA V&V documentation gap analysis, structured non-product software V&V methodology, unit tests, and 21 CFR Part 11 compliance.
Multi-year engagement spanning handle ATE, shaft ATE, closure force test system V&V, design verification tester V&V, stapler test software redevelopment, and V&V consulting for additional ATE in the supply chain.
RF test set for MRI compatibility, MRI field simulation RF injection system, a five-axis robotic arm test set for near-field inductive charging characterization, and modernization of the MRI compatibility test software platform.
Contact lens mold inspection with angle-of-attack illumination, refraction, and light scatter for translucent defect detection; IEC 62304 V&V of an IVD for breast cancer screening; and a CAPA-driven orthopedic implant inspection system with MSA and uncertainty analysis.
21 CFR Part 11 advisory for a Class III SaMD platform managing the chain of custody for cadaver corneas, plus an EHR synchronization architecture for a multi-site healthcare organization across approximately fifty states.
Ultrasound test set hardware abstraction layer still in production with only one bug ticket ever filed against it, novel EKG diagnostic data logging and cardiac signal analysis, FPGA white-box testing and V&V for an electroporation device, and 21 CFR 820.70(i) validation of a COTS LMS.
Structured verification and validation grounded in 21 CFR 820.30, IEC 62304, and 21 CFR Part 11. We deliver requirements traceability matrices, protocol execution, gap analyses, and validation summary reports that hold up under FDA inspection -- including warning letter remediation when the stakes are highest.
Validation per 21 CFR 820.70(i) for software that supports manufacturing and quality but is not part of the device itself -- production test applications, lab databases, analysis scripts, automation frameworks, COTS LMS platforms, and EHR synchronization systems. Risk-based, proportional, and defensible under audit.
Electronic records, audit trails, electronic signatures, and automated PDF test reports architected for 21 CFR Part 11 compliance from the start. We have implemented Part 11-compliant systems for Class III implantables, SaMD tissue tracking platforms, and multi-site production environments.
Automated test equipment for manufacturing lines -- from LVAD pump programming stations and surgical stapler handle/shaft ATE to contact lens mold inspection and blood handling equipment. We build production-hardened systems validated per 820.72(a) with calibration traceability, measurement system analysis, and automated data acquisition.
Five-axis robotic charging characterization, MRI field simulation RF injection fixtures, life cycle durability testers, and motion-controlled alignment rigs. Purpose-built mechanical and electromechanical fixtures for active implants, electroporation devices, and energy-delivering systems where repeatable positioning is non-negotiable.
Gauge R&R, measurement system analysis, and uncertainty budgets per 820.72(a) so pass/fail decisions are defensible. We have performed MSA on CAPA-driven orthopedic implant inspection systems, closure force testers for surgical staplers, and novel optics for translucent defect detection -- ensuring test results are credible and traceable.
Production test systems, V&V deliverables, regulatory consulting, and the software infrastructure that connects them -- built by engineers who understand both the hardware and the quality system.
Every architecture decision intersects 21 CFR 820.30 design controls, 820.70(i) software validation, 820.72(a) calibration requirements, and IEC 62304 software lifecycle processes. We design traceability and evidence generation into the system from the start -- not bolted on after the fact.
LMS platforms, EHR systems, production test applications, and analysis scripts all end up in front of auditors. We have validated COTS LMS per 820.70(i), built Part 11-compliant data systems for multi-site operations, and implemented CI/CD with unit testing for device test software. Proportional, risk-based, and defensible.
From Class III LVAD pump testers to surgical stapler ATE to electroporation FPGA test benches, the test set has to be at least as reliable as the device it measures. We deliver MSA, uncertainty budgets, calibration traceability, and validation packages that make the test system audit-proof.
One team that handles both the engineering and the quality system -- from Class II diagnostics to Class III implants, from production ATE to FDA warning letter remediation.
Program Support
Join your team on a Class III implant program, SaMD platform, production ATE buildout, or FDA remediation effort where test infrastructure is on the critical path.
Modernize And Validate
Replace ad hoc tools with engineered ATE, structured V&V packages per 820.30 and IEC 62304, and Part 11-compliant data systems your quality system can defend under audit.
Train And Transfer
Workshops on 820.70(i) validation methodology, Part 11 implementation, and test method V&V -- plus hands-on implementation, coding standards, and documentation thorough enough for your team to sustain the system independently.
One team that handles both the engineering and the quality system -- from Class II diagnostics to Class III implants, from production ATE to FDA warning letter remediation.
Trusted by
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.
