Sterilization Solutions

Eagle Medical partners with our customers to determine the most efficient and effective sterilization method for each unique project. All Established Category A sterilization modalities are supported.

Quality Assembly & Packaging

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

Allow us to help you navigate every regulatory hurdle that comes with bringing your product to market

Eagle Medical is committed to providing our customers with continued assurance of compliance with today's evolving regulatory requirements.

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.

Eagle offers deep and vast knowledge in the realm of sterilization and, in particular, detailed guidance with our vertically integrated Hydrogen Peroxide Gas Plasma sterilization modality. Assistance with the development and comparisons of full validation and batch release can be provided to OEMs to help you select the best path forward for your project.

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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)

Sterilization Solutions

Eagle Medical is committed to finding the most suitable and efficient sterilization method for our customers' products.

Quality Assembly and Packaging

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

Cleanrooms

ISO 14644-1 Class 7 (Class 10,000) state of the art cleanrooms and laminar flow benches provide the highest standard of sterile environment for your procedures.

Sterilization Solutions

Quality Assembly & Packaging

Allow us to help you navigate every regulatory hurdle that comes with bringing your product to market

Eagle Medical is committed to providing our customers with continued assurance of compliance with today's evolving regulatory requirements.

Our Location

Our Facility

Our Expertise

Contract Assembly & Packaging

Support Services

Inventory Control

Sterilization Solutions

Eagle Medical is committed to finding the most suitable and efficient sterilization method for our customers' products.

Quality Assembly and Packaging

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

Cleanrooms

ISO 14644-1 Class 7 (Class 10,000) state of the art cleanrooms and laminar flow benches provide the highest standard of sterile environment for your procedures.