Medical Device Assembly Line Achieves ISO 13485 Compliance
Cleanroom-compatible assembly system for surgical instruments with full traceability
Project Overview
When a leading medical device manufacturer received FDA clearance for their next-generation minimally invasive surgical instrument, they faced a significant challenge: scaling from prototype production to 50,000 units annually while maintaining the precision and documentation required for Class II medical devices.
Manual assembly was not viable—the instrument contained 23 components requiring sub-millimeter placement accuracy, and FDA regulations demanded 100% traceability of every component and process parameter.
Regulatory Compliance by Design
From the initial concept, our engineering team designed the system to meet regulatory requirements:
21 CFR Part 820 Compliance
- Electronic Device History Records (eDHR) for every unit
- Automatic data collection at each process step
- Secure, tamper-proof audit trail
- User access controls with electronic signatures
ISO 13485 Requirements
- Documented validation protocols (IQ/OQ/PQ)
- Process capability studies (Cpk > 1.33)
- Preventive maintenance scheduling
- Calibration management integration
Cleanroom Compatibility
- All robots rated for ISO Class 5 environments
- FDA-compliant lubricants throughout
- Stainless steel and anodized aluminum construction
- Integrated HEPA filtration at critical stations
Assembly Process
The system performs the complete surgical instrument assembly in a single load:
Station 1: Component feeding and orientation verification Station 2: Precision sub-assembly with force monitoring Station 3: Main body assembly with 0.1mm accuracy Station 4: Functional mechanism test Station 5: Final vision inspection and serialization
Each station captures complete process data linked to the unique device identifier (UDI), creating a comprehensive electronic record that travels with the device throughout its lifecycle.
Validation Success
The validation process proceeded smoothly due to early involvement of the client's quality team:
- IQ (Installation Qualification): Verified all equipment installed per specifications
- OQ (Operational Qualification): Confirmed system operates within defined parameters
- PQ (Performance Qualification): Demonstrated consistent production of conforming product
The FDA inspection following validation resulted in zero Form 483 observations—a testament to the robust design and documentation.
Customer Testimonial
"AMD Automation understood our regulatory requirements from day one. They didn't just build a machine—they delivered a validated manufacturing system that passed FDA inspection with flying colors. The electronic DHR has transformed our quality operations."
— VP of Operations, Medical Device Manufacturer
01The Challenge
The client needed to scale production of a new minimally invasive surgical instrument from prototype to 50,000 units annually while meeting FDA 21 CFR Part 820 requirements and ISO 13485 certification standards.
- Complex assembly requiring sub-millimeter precision
- 100% traceability requirement for all components and processes
- ISO Class 7 cleanroom compatibility required
- Multiple inspection points with documented quality gates
- Validation protocols (IQ/OQ/PQ) required before production
02Our Solution
AMD Automation designed a modular assembly system integrating precision robotics, vision inspection, and a comprehensive data collection architecture that satisfies FDA regulatory requirements while achieving production targets.
Cleanroom-Compatible Robots
FANUC CR-7iA/L collaborative robots with ISO Class 5 rated covers and FDA-compliant lubricants for operation in controlled environments.
Precision Assembly Stations
Force-feedback servo presses with 0.01mm positioning accuracy ensure consistent assembly of delicate components without damage.
Multi-Stage Vision Inspection
High-resolution cameras at 5 inspection points verify component presence, orientation, and assembly quality with documented pass/fail records.
MES Integration
Full integration with client's Manufacturing Execution System provides electronic Device History Records (eDHR) for every unit produced.
03The Results
The system passed FDA inspection with zero findings and achieved full production rate within the first month. Complete electronic traceability has eliminated paper-based quality records and reduced investigation time for any quality events.
Technical Specifications
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