Medical device manufacturing demands the highest levels of precision, cleanliness, and documentation. AMD Automation builds automation systems that meet these requirements while delivering the productivity you need.
Regulatory Expertise
We understand the regulatory environment of medical device manufacturing:
- 21 CFR Part 11 - Our control systems support electronic records and signatures with appropriate access controls, audit trails, and data integrity.
- ISO 13485 - Systems designed to support your quality management system requirements.
- FDA Validation - We provide documentation packages that support your IQ/OQ/PQ validation protocols.
Clean Room Compatibility
For clean room applications, we design systems with:
- Stainless steel construction and appropriate surface finishes
- Clean room compatible components and materials
- Minimized particle generation
- Easy cleaning access
- Laminar flow integration when required
Traceability
Medical device regulations require complete traceability. Our systems capture and record:
- Component lot and serial numbers
- Process parameters for every operation
- Test results with pass/fail status
- Operator identification
- Timestamps for all events
Data integrates with your MES/ERP systems for complete device history records.
Applications
We've built medical device automation for:
- Surgical instrument assembly
- Diagnostic device assembly
- Drug delivery device production
- Implantable device manufacturing
- In-vitro diagnostic equipment
- Medical electronics assembly
Automation Solutions for Medical Devices
Clean Room Assembly
ISO Class 7/8 compatible assembly systems with appropriate materials and construction.
Device Testing
Automated testing for functionality, leak integrity, and electrical safety.
Packaging Systems
Primary and secondary packaging with labeling and serialization.
Component Assembly
Precision assembly of small, intricate medical device components.
Inspection Systems
Vision inspection for defect detection and dimensional verification.
Traceability Systems
Complete part history from component to finished device.
Industry Challenges We Solve
Regulatory Compliance
Our systems support 21 CFR Part 11, ISO 13485, and FDA validation requirements.
Cleanliness Requirements
Clean room compatible materials and designs minimize contamination risk.
Validation Documentation
We provide comprehensive IQ/OQ/PQ documentation packages.
Process Control
Tight process control ensures consistent quality for every device produced.
Let's discuss your specific automation challenges.