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

Engineering Services & Design for Manufacturability

More than an assembler, Eagle is a strategic manufacturing partner, helping ensure your device is optimized for production, packaging, sterilization, and regulatory success.

Engineering Support Includes:

  • Primary package and backer card design/optimization
  • Design for manufacturing (DFM) and component standardization
  • Project management from concept to commercialization
  • FDA submission consulting and documentation preparation
  • Process validations and test planning for regulatory approval
  • Random sample testing and analysis for performance verification

Supply Chain Confidence, Built In

At Eagle Medical, we don’t just build your product, we protect your timeline. As a supply chain–conscious CMO, we act as a stabilizing force across your entire production lifecycle. From raw material coordination to just-in-time scheduling and validated packaging supply, our systems are designed to prevent the delays, shortages, or breakdowns that jeopardize delivery and revenue.

Our Supply Chain Advantage:

  • Redundant access to critical materials like Tyvek®, multilayer films, and sterile barrier systems
  • In-house cleanroom packaging, kitting, labeling, and sterilization prep, no handoffs
  • Vendor and component management aligned with your forecasting and regulatory needs
  • Lean inventory support, batch traceability, and fast-turn cycle times
  • Risk mitigation strategies to insulate your production against global disruptions We’re here to keep your devices moving, from controlled cleanrooms to the hands of healthcare providers, with speed, consistency, and confidence.

Scalable. Flexible. Ready When You Are.

With facilities purpose-built for speed and regulatory compliance, we flex our operations to support you at every stage, early concepting, clinical validation, or commercial rollout. Our fast, adaptable model means shorter lead times, easier onboarding, and solutions that scale with your business. We specialize in helping device companies reduce friction, eliminate bottlenecks, and move from design to delivery in weeks, not months.

Markets We Support:

  • Implants & Interventions: Active Implants, CRM, Neurostimulation, Neuromodulation
  • Vascular & Cardiovascular: Neurovascular, Peripheral, Cardiovascular
  • Minimally Invasive & Robotic Surgery: Advanced MIS Instruments, Robotic Systems, Surgical Tooling
  • Orthopedics: Spine, Joint, Trauma, Extremities, Sports Medicine, Reconstruction
  • Diagnostics & Digital Health: Wearables, ICMs, Patient Monitoring, IVD
  • Other Specialties: Drug Delivery, Ophthalmic, Dental, Diabetes, Pharmaceutical , and more

Why Eagle?

Because your device deserves more than a vendor, it needs a partner. One with speed, flexibility, and proven performance across regulated manufacturing. One that helps you keep your medical promise, from cleanroom to clinic, from prototype to patient.

Sterile Assembly

Sterile 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 Support

Supply Chain Support

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