ISO 13485 Certified Manufacturing You Can Trust
FDA-focused approach with validated processes. Quality systems that ensure regulatory-ready production every time.
Compliance Isn't Just a Checkbox — It's Your Product's Future
These are the questions that keep quality leaders up at night.
"Will our CMO really understand FDA requirements?"
"What if their quality systems cause delays?"
"Can they handle 510(k) documentation requirements?"
"Will they maintain compliance during production scaling?"
Quality-First Manufacturing With Regulatory Expertise
Every document, every process — designed with compliance in mind.
ISO 13485 Certified Quality Systems
- Comprehensive quality management
- Document control and traceability
- Regular internal and external audits
- Continuous improvement processes
Full-Service Manufacturing
- Process Development/Documentation
- Receiving Inspection
- Inventory Management
- Any production size — pilot builds to high volume manufacturing
- Fulfillment
Our Difference
- 30+ years of medical device manufacturing experience
- Small, Woman-owned company
- Responsive to customers' timelines, values, and priorities
- More than a critical supplier, A&M is your manufacturing partner
Quality Metrics That Speak for Themselves
Regulatory Support Services
Design Control Documentation
Complete design history files and documentation packages
Process Validation Support
IQ/OQ/PQ protocols and execution documentation
Change Control Management
Structured change management with full traceability
Supplier Qualification Assistance
Vendor audits, qualification protocols, and ongoing monitoring
Ensure Your Device Meets Every Regulatory Standard
Let us review your compliance needs and show you how our quality systems can support your regulatory goals.
- Free compliance gap assessment
- Review of current quality documentation
- Regulatory pathway recommendations
- Response within 24 hours
