Medical Device
Change control, CAPA, and compliance documentation that runs on structured systems instead of email chains. Built for medical device companies where audit readiness is a requirement.
Sound Familiar?
Most medical device companies have strong engineering and compliance teams. The problem is the systems underneath them, 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 causes disruption, and pricing changes need manual workarounds.
What We Build
01
We build approval workflows that enforce structured review and sign-off for engineering changes, deviations, and document revisions, with audit trails, electronic signatures and version control built in from the first release.
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 for audit readiness from the start: decision logging, explanations for AI recommendations, a person approving the decisions that matter, and structured data that supports regulatory submissions without a scramble.
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 Azure AD sign-in.
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 that surfaces the most effective product configurations based on historical win rates, plus automated pricing anomaly detection.
Start Here
If you are weighing AI for quality or regulatory work, the Blueprint is a short readiness assessment. Your people each spend 10 to 15 minutes in an anonymous interview, and we come back with a scored report covering the first workflows worth taking on, the governance gaps to close, and what has to be in place before any development begins. The fee is credited toward implementation.