Contract Manufacturing

Contract Manufacturing

Precision-Built. Purpose-Driven. Partner-Aligned.

At Eagle Medical, contract manufacturing is more than a service, it's a promise. A promise to deliver cleanroom-assembled medical devices with unmatched precision, speed, and regulatory readiness.


Whether you're building a new prototype or scaling for global release, we act as an agile extension of your team, combining ISO-certified environments, advanced process controls, and seasoned regulatory expertise to move your vision forward.

We specialize in high-quality, fast-turn, cleanroom-based manufacturing support for medical innovators, whether you're a startup racing to market or an established OEM scaling production with full compliance.


End-to-End Manufacturing Services

We offer a seamless integration of services tailored to your device, timeline, and regulatory pathway, from early prototyping to validated commercial manufacturing.

Core Capabilities:

  • Bonding, fastening, and sealing processes validated for strength, sterility, and durability
  • Custom kitting and sterile assembly for surgical accessories and procedural kits
  • Rapid prototyping and low-volume manufacturing for R&D and clinical trial phases
  • Full-scale production capacity with short lead times and scalable labor deployment
  • Flexible manufacturing for small-batch runs or variable SKUs across product lines
  • Expertise in assembling spinal implants, catheters, sutures, instruments, electronics, and more
  • Integrated packaging, sterilization prep, and post-process traceability built in

Built on Quality from Day One

Quality isn't a phase, it's our foundation. Our processes are engineered to support the full lifecycle of your product with accuracy, traceability, and confidence.

Our Quality Infrastructure:

  • ISO 13485:2016 certified manufacturing systems
  • FDA 21 CFR Part 820 compliant design controls
  • Statistical process control (SPC) to ensure measurable, repeatable outcomes
  • Full device history records (DHRs) and audit-ready documentation sets
  • Validation-ready systems with IQ/OQ/PQ processes and testing support
  • Dedicated QA/QC teams ensuring traceability and performance at every step
  • Cleanroom certifications to ISO Class 7 (environment) and ISO Class 5 (benches)
  • Process validations, random sample testing, and pre- and post-sterilization checks
Cleanroom Assembly

Cleanroom Assembly

Streamline your device manufacturing with integrated assembly and sterilization. Eagle Medical reduces handoffs, transit risk, and time-to-market, all while upholding uncompromising sterile processing standards.

Sterile Barrier Packaging Solutions

Sterile Barrier Packaging Solutions

Engineered Sterile Barrier Packaging Solutions for Regulatory Confidence & Sustainability At Eagle Medical, we design and manufacture sterile barrier packaging systems that protect medical devices throughout the distribution environment, ensuring sterility, usability, and compliance from production to point-of-care. Every packaging configuration is engineered for regulatory alignment, aseptic presentation, and reduced material footprint, offering a sustainable alternative.

Engineering Services

Engineering Services

Eagle Medical partners with clients to optimize sterile packaging, validate processes, and streamline regulatory documentation. Our engineering support ensures faster approvals, stronger compliance, and smarter design, from first article to final release.

Adhesive, Bonding & Fastening Operations

Adhesive, Bonding & Fastening Operations

Our engineers validate the best way to hold your product or packaging together, using pull and drop testing to optimize adhesive, bonding, and fastening techniques. Every solution is tested, verified, and proven for your device’s specific use case.

Additive Manufacturing

Additive Manufacturing

We offer limited 3D printing capabilities to support prototype development and part production when needed. This helps accelerate solutions and streamline progress during complex builds or early-stage product iterations.

Supply Chain Services

Supply Chain Services

Eagle Medical safeguards your timelines and de-risks your launch with integrated CMO services, expert sterilization and packaging, pre validated systems, and supply chain resilience you can count on.

Ready to Get Started?

Contact our experts to discuss your specific medical device needs and find the right solution for your project.