Hire an AI workforce built for medtech.
Evolving Technologies designs AI agents for pharma and medical device teams. They draft regulatory and quality documentation, triage complaints and adverse events, and handle medical information requests, so your regulatory, quality, and commercial teams can focus on getting products to market.
- Complaint & inquiry intake
- 24/7
- Rip-and-replace of your QMS
- 0
- Agent actions logged for audit
- 100%
Complaint & inquiry intake
Rip-and-replace of your QMS
Agent actions logged for audit
An AI workforce that fits how regulated product teams actually work
Designed for GxP environments
Workflows are built with 21 CFR Part 11 and ISO 13485 expectations in mind: audit trails, access controls, and documented human sign-off.
Regulatory drafting support
Agents assemble first drafts of submission sections, labeling updates, and technical file content from your source documents, ready for RA review.
Complaint & AE intake, 24/7
Product complaints, adverse event reports, and medical information requests are captured, classified, and routed to the right team around the clock.
Quality documentation, faster
CAPA records, deviation summaries, SOP revisions, and design history file updates are drafted from your data, so QA reviews them instead of writing them.
Works inside your stack
Connects to the eQMS, regulatory information management, CRM, and ERP systems you already use. No migrations or rebuilds.
Humans stay in control
Every AI action is reviewable, reversible, and logged, so your team always has visibility and the final word.
From pilot workflow to full AI workforce
Discover
We map your highest-friction workflows, such as complaint handling, CAPA, regulatory drafting, and medical information, along with your quality and validation requirements.
Design
We scope AI agents to specific, bounded tasks and define exactly where human checkpoints are required.
Deploy
We roll out inside your existing systems with a phased pilot and the validation documentation your quality team needs, starting with one workflow before expanding.
Refine
We monitor performance with your team and expand the AI workforce as trust and results build.
Evolving Technologies is a focused, early-stage partner
We're not claiming a decade of medtech case studies. What we bring is a disciplined build process, compliance-first engineering, and a commitment to keep your team in control of every AI action from day one.
Compliance-first engineering
Audit logging, access controls, data integrity (ALCOA+), and validation support are designed in from the start, not bolted on afterward.
Human-in-the-loop by default
AI agents propose and draft. Your RA, QA, and safety staff approve anything regulatory, quality-related, or patient-safety-related before it goes out.
Integration-ready architecture
Built to connect to common eQMS, RIM, safety, CRM, and ERP platforms through their existing APIs and interfaces.
Questions medtech teams ask us
See where an AI workforce fits in your operation
Book a 30-minute workforce assessment. We'll map your highest-volume administrative workflows and show you exactly where AI agents can take on repetitive work under your team's oversight.
- No commitment required
- Compliance-first scoping
- Answers within 1 business day