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