Services

Eagle Medical offers its customers a full range of services to meet their medical device assembly, packaging, and sterilization needs.

Contract Assembly & Packaging

• FDA Regulatory Support - 510(k), and Pre-Market Approval (PMA)
• Quality Standards / ISO 13485
• Complete GMP Compliance
• Purchasing Services
• Packing Design
• Tooling Design & Fabrication
• Assembly Capability
• Regulatory & Microbiology Support
• Contract Sterilization (VHP Gas Plasma, EtO, Gamma)
• Flexibility to Accommodate Short & Long Run Projects
• Competitive Pricing

Support Services

• Purchasing/Vendor Audits
• Incoming Inspection (to verify specifications of packaging materials)
• Documentation
• Device Master Records
• Procedures
• Batch Records
• Inspection Records
• Process Validation
• Protocol Development
• Testing Coordination
• Data Analysis
• Final Reports
• Sterilization Validation
• Engineering

Inventory Control

• Computerized Tracking System of Customer Inventory
• Available MIN/MAX System for Automatic Adjustment of Customer's Raw Material
• Monthly Inventory Reports (fax and/or email)