Eagle Medical is committed to partner with our customers ain finding the most efficient sterilization methodology to speed market penetration.

Eagle Medical is certified to requirements of ISO 13485:2016 for contract packaging and sterilization of medical products.

Our Location: Eagle Medical is located on the beautiful Central Coast of California mid-way between San Francisco and Los Angeles.
Our Facility: Our modern 20,000 square foot facility was designed to exceed today's regulatory requirements and has over 2500 square feet of cleanroom and support area designed to provide a high quality environment for assembly and packaging of Medical Devices.
Our Expertise: Eagle Medical's areas of expertise include manufacturing and packaging specialties, process and sterility validation studies, environmental controls, and bringing new products to market.

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Contract Assembly & Packaging: Contract Sterilization (Hydrogen Peroxide Gas Plasma, E-beam, EtO, Gamma)

Contract Packaging and Assembly

Last Process Steps (Cleaning and Disinfecting)

FDA Regulatory Support - 510(k), and PMA

Quality Standards ISO 13485:2016 Certified; Audited in accordance with ISO 22441:2022

Complete GMP Compliance

Purchasing Services

Packaging Design

Tooling Design & Fabrication

Regulatory & Microbiology Support

Flexibility to Accommodate Short & Long Run Projects

Competitive Pricing
Support Services: Sterilization Validation

Packaging Validation

Cleaning Validation

Process Validation

Purchasing/Vendor Audits

Incoming Inspection (to verify specifications of packaging materials)

Documentation

Device Master Records

Procedures

Batch Records

Inspection Records

Protocol Development

Testing Coordination

Data Analysis

Final Reports
Inventory Control: Computerized Tracking System for Customer Inventory

Available MIN/MAX system for automatic adjustment of customer's raw material

Monthly Inventory Reports (fax and/or email)

Customer Specific Web Portal Access (under construction)