Med device & medtech
AI workflows that behave like quality systems
We build traceable AI for postmarket, investigations, and quality documentation with review steps and monitoring, deployed to fit your environment.
Governance, simplified
Built-in controls that keep quality and compliance teams aligned.
- Outputs link back to sources
- High-risk steps require human approval
- Quality is monitored over time
Where we help
- Complaint intake and classification support
- Investigation and CAPA narrative drafting support
- Postmarket surveillance summarization
- Supplier quality documentation workflows
- Consistency checks and exception handling
Example output: investigation and CAPA drafts with evidence links and reviewer checkpoints.
1
Step 1
Ingest
Complaints, investigations, and quality docs.
2
Step 2
Review
Reviewer gates for CAPA and investigations.
3
Step 3
Monitor
Audit trails and quality metrics.
What you get
Inputs: complaint records, investigation notes, and quality documentation. Outputs: controlled drafts, audit logs, and reviewer queues.
- Documented behavior with reviewer approvals and audit trails
- Audit trails and reviewer queues
- Evaluation tests + ongoing monitoring
- Deployment in your environment (VPC or on-prem)
Proof
Anonymized case: postmarket surveillance summaries and CAPA drafting with traceable evidence.