Name

Eagle Medical

Legal name

Eagle Medical Packaging Sterilization, Inc.

Website

https://eaglemed.com

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

51–100 employees

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers) (HLAHANAB)

akta.pro secondary industry

Manufacturing Quality, GMP Inspections & Compliance (HLAJADAG)

Keywords

• Medical device sterilization
• Contract manufacturing
• Sterile barrier packaging
• Cleanroom assembly
• Regulatory validation services

Headquarters

HQ city

Paso Robles

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Supply Chain, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Sterilization Services: Provides multiple sterilization modalities including Hydrogen Peroxide Gas Plasma (HPGP), E-beam, Gamma irradiation, and Ethylene Oxide (through partner Blue Line). Revenue generated through per-batch processing fees based on volume and cycle requirements. As the largest H2O2 contract sterilizer in North America with up to 8 dedicated sterilizers, this represents a core revenue stream.
2. Contract Manufacturing and Assembly: Cleanroom assembly services for medical devices including component assembly, kit assembly, and full finished device manufacturing. Flexible production accommodating volumes from thousands to one million units annually. Revenue based on production volume and complexity.
3. Sterile Barrier Packaging Solutions: Design, manufacturing, and validation of packaging systems including thermoformed trays, pouch systems, backer cards, and protective barriers. Includes custom packaging, pre-validated options (PATH, ReadiPouch), and off-the-shelf pouch sales.
4. Validation Services: Comprehensive validation services for sterilization, packaging, cleaning, and manufacturing processes. Includes protocol development, testing coordination, and documentation for regulatory submissions (FDA 510(k), PMA).
5. Regulatory Support Services: FDA regulatory support including 510(k) and PMA submissions, quality system compliance, and microbiology support services.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels8 records

Core offering

Eagle Medical is a medical device contract manufacturing organization providing FDA-compliant cleanroom assembly, sterile barrier packaging design and validation, and contract sterilization services (HPGP, E-beam, Gamma, EtO). Its portfolio centers on proprietary pre-validated packaging solutions—PATH True-Validated and ReadiPouch—combined with in-house HPGP sterilization, supporting medical device OEMs from prototype through commercial production.

Product overview

Eagle Medical is a medical device packaging and sterilization service provider offering an integrated platform of contract manufacturing, assembly, packaging, and sterilization services for the medical device, pharmaceutical, and biotech industries. The portfolio consists of four flagship packaging products — PATH™ (True-Validated pre-validated packaging enabling 3-week FDA submissions), ReadiPouch™ (pre-configured, pre-validated drop-in-and-go packaging), Custom Pouches (4–6 week custom Tyvek pouch solutions), and Off The Shelf Pouches (standard catalog pouches) — supported by four sterilization modalities (Hydrogen Peroxide Gas Plasma, E-Beam, Gamma, and Ethylene Oxide) and a full suite of manufacturing services including cleanroom assembly, sterile barrier packaging solutions, engineering services, adhesive/bonding operations, additive manufacturing, supply chain services, packaging conceptual design, preliminary testing, manufacturing process instruction development, and sterilization/packaging/cleaning validations. The company also provides three web-based calculator tools (Accelerated Aging Calculator, Pack Out Calculator, and Project Timeline Calculator). Eagle Medical operates an ISO 13485:2016 certified facility on the Central Coast of California with over 2,500 square feet of ISO Class 7 cleanroom space.

Differentiator

Problem solved

Functional benefit

Brands

• PATH™: Packaging Accelerated Timeline Help - True-Validated packaging solution that completes packaging development in under 3 weeks.
• ReadiPouch™

Products and services

• PATH™ (Packaging Accelerated Timeline Help) True-Validated pre-validated packaging system that compresses medical device packaging development timelines to under 3 weeks and enables FDA submission by eliminating the need for OEMs to design, build, validate, or test packaging; includes a complete submission-ready document set (IQ/OQ/PQ, material certs, test data) and an FDA Master File reference
• ReadiPouch™ Drop-in-and-go pre-configured, pre-structured, and pre-validated medical device packaging solution with menu-selectable sizes, fully configured secondary packaging, structured Bill of Materials, and pre-validated seals; in-house materials on the shelf to eliminate lead times
• Custom Pouches Custom Tyvek pouch systems designed and produced in 4-6 weeks, supporting single/double-barrier configurations, backer cards, thermoformed supports, protective vials, and kitted combinations for multiple sterilization modalities
• Off The Shelf Pouches Direct purchase of standard, known pouch configurations in bulk quantities, enabling teams to skip primary packaging design and redirect engineering resources toward device optimization
• Hydrogen Peroxide Gas Plasma (HPGP) Sterilization In-house FDA-recognized Established Category A low-temperature sterilization using vaporized hydrogen peroxide gas plasma via Sterrad 200 and Steris VHP systems; approximately 2-hour cycle time, operating temperature below 55°C, ~270-liter chamber volume (150 liters payload), and 48-72 hour product turnaround; compatible with electronics, batteries, and orthopedic implants
• E-Beam Sterilization High-energy electron beam sterilization service provided through partnership with Steri-Tek in Fremont, CA, compliant with ISO 11137; one of the fastest sterilization methods available, suitable for low-density packaging, with no radioactive materials required
• Gamma Beam Irradiation Cobalt-60 gamma ionizing irradiation sterilization service offering deep penetration for dense products and packaging, effective on fully packaged materials including some liquids, with mild temperature process parameters

Quantifiable outcome

• Packaging development timeline reduced from 9-12 months to under 3 weeks
• +5 more outcomes

Named customers25 records

Segments5 records

Ideal customer profiles3 records

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Four partnerships are on record, tiered core.

• West PakcoreStrategic or Co-development Partner · 1 February 2024West Pak is a third-party, independent laboratory specializing in package validation and product testing. Founding member of the West Coast Device Alliance (WCDA) alongside Eagle Medical, providing complementary packaging validation services for integrated customer solutions.
• Pacific BioLabscoreStrategic or Co-development Partner · 1 February 2024Pacific BioLabs is a contract research organization specializing in microbiology, services for living organisms in vivo, and analytical chemistry and cell-based bioassay culture samples in vitro for medical device and pharmaceutical industries. WCDA founding member.
• Blue Line Sterilization ServicescoreStrategic or Co-development Partner · 1 February 2024Blue Line Sterilization Services specializes in ethylene oxide (EO) sterilization services. WCDA founding member providing EtO sterilization complementing Eagle Medical's HGP capabilities.
• Steri-TekcoreStrategic or Co-development Partner · 1 February 2024Steri-Tek is a high-volume E-beam and X-ray contract sterilizer as well as R&D innovation center. WCDA founding member providing high-volume irradiation sterilization services.

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Westpak: Independent third-party package testing and validation laboratory. WCDA partner offering package validation services that complement and partially overlap with Eagle's PATH and sterile barrier offerings.
• Sterigenics (Sotera Health): Largest global contract sterilization provider (EtO, Gamma, E-beam) and Eagle Medical's most direct competitor across medical device OEMs. Comparable in serving Class II/III device manufacturers requiring validated sterilization and regulatory support.
• Pacific BioLabs: CRO specializing in microbiology, in vivo biocompatibility, and analytical chemistry for medical devices. WCDA partner that overlaps with Eagle's validation and regulatory support services.
• Steri-Tek: High-volume E-beam and X-ray contract sterilizer and R&D innovation center in Fremont, CA. WCDA partner that also competes for irradiation sterilization volumes on the West Coast.
• Blue Line Sterilization Services: EtO-focused contract sterilizer based in Novato, CA. WCDA partner and complementary competitor offering the EtO modality that Eagle Medical does not operate in-house.
• Nelson Laboratories (Steris): Medical device microbiology and sterilization testing laboratory, now part of STERIS. Competes directly with Eagle's validation services and supports many of the same Class II/III medical device OEMs.

Broad incumbents

• STERIS: Diversified sterilization, infection prevention, and medical device services giant. Operates contract sterilization and laboratory testing services alongside its capital equipment business, directly overlapping with Eagle's HPGP and validation offerings.
• Becton Dickinson (BD): Global medical device manufacturer with extensive in-house sterilization operations and a contract services arm. Competes with Eagle Medical both as a buyer of contract sterilization and as a vertically integrated alternative for OEMs.
• WuXi AppTec: Large global CDMO with medical device testing and sterilization services. Serves pharma and medical device customers with similar sterilization and validation requirements as Eagle.
• Eurofins Medical Device Services: Global testing, certification, and laboratory services group serving medical device OEMs with biocompatibility, sterilization validation, and packaging testing. A broader, multi-region competitor to Eagle's validation and testing services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/eagle-medical-inc.

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Eagle Medical