Client References
Complex systems. Demanding deadlines. Proven contributions.
Keystone Medical Device Partners, formerly Advantu.
From connected hospital systems to laboratory automation and audit preparation, see how our team has helped clients test complex technology, resolve quality gaps, and move projects forward.
5,000 infusion pumps
Integration and performance testing of a hospital system connected through 500 docking stations.
Multiple laboratories
T-SPOT OS enabled remote operation and management of TB testing instruments across multiple laboratories.
Zero software-validation findings
Argen passed its MDSAP audit following software-validation readiness assessment and remediation support.
Risk ID in System V&V:
Project Examples
These projects used the Risk ID process to inform system verification and validation and were subsequently released or implemented successfully.
Oxford Immunotec
Project: Advantu designed, developed, and tested T-SPOT OS, enabling operators to remotely manage TB testing instruments across multiple laboratories. The team also provided software quality, testing, and regulatory support for an FDA submission.
Risk ID application: Identified and prioritized scenarios for application testing and system verification and validation.
Outcome: The client credited Advantu with helping meet FDA submission demands. T-SPOT OS was delivered to customers in Japan, reducing processing time and manual intervention. According to the client reference, it supports the majority of patient TB testing in Japan.
Mike McAndrew — Director, Program Management
Hospital Infusion System Integration
Project: Kris Kelly led integration and performance testing for a hospital system connecting 500 docking stations and 5,000 infusion pumps, allowing clinicians to view patient status across wards.
Risk ID application: Clinicians, usability experts, developers, and software quality teams generated and prioritized hundreds of “what if” scenarios covering data flows, connectivity interruptions, response times, and connected-device loads.
Testing and resolution: Testing exposed slow responses, intermittent connectivity, alarm-impact issues, and data-flow bottlenecks. Targeted testing and server monitoring helped developers identify root causes and verify fixes, while establishing a reusable performance-testing framework.
Outcome: The system was successfully implemented at six EU sites.
Software Quality Engineering & Test
Modular Medical, Inc.
Project: Advantu supported a medical device startup by refining its software practices and program-management approach.
Outcome: The client credited the work with helping the company use limited resources efficiently while creating business and customer value.
Kevin Hughes — Director of Software Engineering
Accriva Diagnostics
Project: Advantu provided software quality engineering, technical writing, and hardware-test support across multiple projects.
Outcome: The client reported that this support enabled the company to meet project commitments, milestones, and scheduling demands.
Shawn Sanders — Program Manager
Clarify Medical
Project: Advantu provided software quality-assurance and testing resources for a medical device and its physician/patient portal interface.
Outcome: The client reported that Clarify successfully released the product with high quality and reliability.
Don Canal — Executive Team
QMS, Audit & Certification
LI-COR Biosciences
Project: Advantu assessed LI-COR’s database upgrade for alignment with FDA 21 CFR Part 11 and provided recommendations for engineering, quality, and regulatory compliance.
Outcome: The client reported that the recommendations were clear and easy to implement, expressed satisfaction with the results, and recommended Advantu’s support.
Michael Furtaw, Ph.D. — Director of R&D (Biotechnology)
Synthetic Genomics, Inc.
Project: Advantu performed the analysis, developed the plan, and supported implementation of a new DNA synthesis instrument within the company’s GMP workflow.
Outcome: The client endorsed Advantu’s contribution and recommended the team for quality process support.
Steve Speers — Quality Systems Manager
IRRAS, Inc.
Project: Advantu conducted a Design History File gap analysis during preparation for a GMED CE Mark submission and helped remediate critical elements to the Medical Device Regulation standard.
Outcome: The client reported that Advantu delivered more than expected under an exceptionally tight timeline.
Adam Sampson — VP of Product Excellence
The Argen Corporation
Project: Advantu assessed the company’s software-validation readiness and provided remediation assistance in preparation for an MDSAP audit.
Outcome: Argen passed the audit with no software-validation findings. The client recommended Advantu for quality and software-validation support.
Julie Woolf — COO
Hawkins, Inc.
Project: Advantu assessed several systems, identified intended-use validation gaps, and provided a plan to close them.
Outcome: The client reported that Advantu’s professional deliverables established the foundation for the next steps in its validation process.
Nancy Hegdahl — Quality Manager (North)
Additional Experience: Cybersecurity
MixMode
Project: Advantu provided support to address the company’s performance-scaling needs.
Outcome: The client reported consistently positive experiences working with Kris and the team and confirmed that they efficiently provided the performance-scaling solution required.
Cybersecurity Executive
What does your team need to prove before its next release or audit?
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