Medical Device
Change control, CAPA, and compliance documentation that runs on structured systems — not email chains. Built for medical device companies where audit readiness isn't optional.
Sound Familiar?
Most medical device companies have strong engineering and compliance teams. The problem is the systems underneath those teams — built on tools that were never designed for this level of regulatory accountability.
Engineering change orders circulate through inboxes and shared drives. Version history is unclear, approval chains are informal, and audit preparation is a scramble.
Corrective action processes run on static forms and manual follow-up. Recurrence risks go undetected until the next audit surfaces the same issue.
DHF and DMR documentation is scattered across systems. When a submission or audit arrives, teams spend weeks assembling evidence that should already be structured and linked.
Sales teams rely on quoting and configuration tools built on aging native apps. Every platform update creates disruption. Pricing changes require manual workarounds. The risk compounds.
What We Build
01
We build approval workflows that enforce structured review and sign-off for engineering changes, deviations, and document revisions — with full audit trails, electronic signatures, and version integrity built in from day one.
02
We replace manual CAPA processes with structured workflow systems that track root cause, corrective actions, effectiveness checks, and recurrence. AI layers surface patterns across incidents before they become systemic issues.
03
Every system we build is designed with audit readiness as a first principle — decision logging, explainability, human-in-the-loop oversight, and structured data that supports regulatory submissions without a fire drill.
We don't start with technology. We start with your workflows — mapping where decisions slow down, where compliance risk surfaces too late, and where the audit trail has gaps. The system we build is a direct response to what we find.
Client Work
Axonics — Medical Device
Axonics relied on an iPad-native quoting tool used by over 300 sales personnel daily. Every iOS update caused disruptions. Pricing changes required manual workarounds. With the original developers unavailable, Axonics had no path forward on a tool the entire field team depended on.
Read the full case studyWhat We Built
A cloud-based web application on Microsoft Azure replacing the native iPad app — with real-time ERP pricing integration, PDF quote generation, and enterprise-grade Azure AD authentication.
Outcome
Zero downtime in the year following deployment. 300+ sales personnel and executives served. Pricing updates flow automatically from the ERP. Axonics was subsequently acquired by Boston Scientific for approximately $2 billion.
Intelligence Opportunity
AI-assisted quote optimization surfacing the most effective product configurations based on historical win rates — and automated pricing anomaly detection.
Start Here
Our Intelligent Workflow Blueprint is a 1–2 week structured engagement that maps your processes, identifies compliance risk, and gives you a clear picture of where AI can reduce operational drag — before any development begins. The Blueprint fee is credited toward implementation.