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Assembly, Packaging & Kitting

Life Science Outsourcing provides comprehensive assembly, packaging, and kitting solutions tailored to the unique needs of medical device manufacturers. We streamline the process from component assembly to sterile and non-sterile packaging, ensuring compliance with regulatory requirements and optimizing supply chain efficiency.

Seamless Assembly, Packaging & Kitting for Faster, Scalable Medical Device Success

LSO delivers fully integrated assembly, packaging, and kitting solutions designed to help startups bring innovations to market faster and large OEMs scale production efficiently. With cleanroom-controlled assembly, validated sterile packaging, and custom procedural kitting, we ensure regulatory compliance, supply chain efficiency, and accelerated commercialization—all under one roof. Whether you need pre-validated packaging, custom kits, or scalable solutions, our expertise helps you reduce costs, eliminate delays, and get your devices into the hands of healthcare providers—faster.

What is Assembly, Packaging & Kitting?

Medical device assembly, packaging, and kitting involve the integration of components, secure packaging, and bundling of products for efficient distribution.

  • Assembly: Cleanroom-controlled assembly of single-use and reusable medical devices.
  • Packaging: Validated sterile and non-sterile packaging configurations, including pouches, trays, and custom packs.
  • Kitting: Custom kits tailored for specific procedures, reducing prep time and ensuring regulatory compliance.
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Who Needs Assembly, Packaging & Kitting?

  • Medical device OEMs requiring contract assembly and packaging services.
  • Distributors & suppliers looking for efficient kitting solutions.
  • Hospitals & surgical centers needing pre-packaged, procedure-ready kits.
  • Startups & emerging companies seeking scalable packaging solutions for new products.

How Does Assembly, Packaging & Kitting Work?

  1. Component Sourcing & Inspection: LSO sources high-quality components and performs rigorous inspections to ensure compliance with industry standards and customer specifications.
  2. Controlled Environment Assembly: Our cleanroom facilities provide a contamination-free environment for medical device assembly, ensuring product integrity and compliance with regulatory requirements.
  3. Packaging & Labeling: Products are packaged according to sterilization requirements, and labels are applied to meet FDA and ISO standards for traceability and compliance.
  4. Kitting & Bundling: Components are grouped into pre-configured kits to streamline distribution and simplify use in clinical settings.
  5. Regulatory Compliance & Validation: Our team conducts full validation and traceability processes to ensure all packaged products meet required safety and performance standards.
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What standards apply?

  • ISO 13485 – Quality management system for medical devices.
  • FDA 21 CFR Part 820 – U.S. FDA quality system regulation.
  • ISO 11607 – Packaging validation for terminally sterilized medical devices.
  • GMP (Good Manufacturing Practices) – Ensuring quality and safety in medical device manufacturing.

Why LSO?

  • End-to-end solutions: From assembly to distribution, all under one roof.
  • Regulatory expertise: Compliance with FDA and ISO standards.
  • Scalability: Flexible services that grow with your business.
  • Quality assurance: Rigorous inspections and process controls ensure device integrity.

Full EtO Validation

Comprehensive packages for regulatory compliance.

Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

Robust Qualification

Secure with 2X qualification.

Choice of PCDs

Tailored to your sterilization needs.

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