Sterile Assembly

Sterile Assembly

Fewer handoffs. Less risk. Faster to market.


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ISO-certified cleanroom assembly combined with industry-leading sterilization services. From simple subcomponents to complex finished devices with precision and documentation.

At Eagle Medical, sterile assembly is more than a clean process—it's a seamless extension of your product's life cycle. We combine ISO-certified cleanroom assembly with our industry-leading sterilization services to deliver fully integrated, regulatory-ready solutions.

Our highly trained teams assemble everything from simple subcomponents to complex finished devices, always with the precision, cleanliness, and documentation that medical applications demand.

Integrated Assembly Services

  • ISO Class 7 & 8 Cleanroom Operations

  • Component Assembly: From sub-assemblies to high-complexity finished goods

  • Kit Assembly: Customized surgical kits, trays, and procedure sets

  • Packaging Integration: Direct transition from assembly into validated sterile packaging workflows

Designed for Manufacturing Efficiency

We tailor our assembly services to meet your unique production needs, whether you're scaling up, iterating a prototype, or building custom clinical trial units.

Manufacturing Efficiency Quality Built-In

We tailor our assembly services to meet your unique production needs, whether you're scaling up, iterating a prototype, or building custom clinical trial units.

Key Considerations:

  • Ease of implementation and tech transfer

  • Specific process requirements and tolerances

  • Ancillary equipment and tooling integration

Every assembly project is executed under rigorous quality control protocols, ensuring performance, traceability, and regulatory confidence:

  • Client defined in-process inspection

  • Validated assembly and process controls

  • Full documentation trail for traceability and audit readiness

  • Compliance with ISO 13485 and FDA 21 CFR Part 820