Medical device manufacturers operate in one of the most highly regulated environments in the world. From surgical instruments and diagnostic equipment to implantable devices, every product must meet strict standards for cleanliness, accuracy, and traceability. Ensuring compliance with FDA regulations, ISO certifications, and Good Manufacturing Practices (GMP) is not just about meeting requirements—it’s about safeguarding lives.

Kardex supports medical device manufacturers with automated storage and retrieval solutions designed for clean, controlled, and audit-ready operations. Our systems help reduce human contact, protect sensitive components, and enable complete visibility across the supply chain. Whether you're scaling production or improving inventory control, Kardex solutions offer the precision and reliability needed to maintain quality and compliance at every stage.

Features & Benefits

  • Regulatory Compliance Support

    Maintain full audit trails and align with FDA, GMP, and ISO standards

  • Climate Controlled Storage

    Protect temperature sensitive components

  • Cleanroom Compatible Solutions

    Minimize contamination risk with enclosed, ISO-class-ready solutions

  • Real Time Inventory Tracking

    Gain instant visibility into part counts, locations, and inventory transactions

  • Accurate Order Fulfillment

    Improve picking precision with guided workflows and ergonomic access

  • Optimized Space Utilization

    Reduce floor space up to 85% with vertical, high-density storage systems

Regulatory Compliance Support

Maintain full audit trails and align with FDA, GMP, and ISO standards

Climate Controlled Storage

Protect temperature sensitive components

Cleanroom Compatible Solutions

Minimize contamination risk with enclosed, ISO-class-ready solutions

Real Time Inventory Tracking

Gain instant visibility into part counts, locations, and inventory transactions

Accurate Order Fulfillment

Improve picking precision with guided workflows and ergonomic access

Optimized Space Utilization

Reduce floor space up to 85% with vertical, high-density storage systems

Smarter Storage for Growth | Intech

Learn how Intech leveraged Kardex automation to streamline inventory access, reduce floor space, and utlimately increase speed to market.

Automation for Precision & Compliance

In an industry where even the smallest mistake can have critical consequences, medical device manufacturers face relentless pressure to meet high quality and safety standards. Compliance with Good Manufacturing Practices (GMP), FDA regulations, and ISO certifications is essential—not optional.

Meet The Strictest Standards—Without Sacrificing Speed or Space

Kardex automated storage and retrieval solutions provide the accuracy, traceability, and environmental control necessary to operate confidently in this highly regulated space. Designed to integrate seamlessly into cleanroom and climate-controlled environments, our systems reduce human contact, protect sensitive materials, and deliver pinpoint inventory control.

Why Medical Device Companies Choose Kardex

  • Maintain hygienic storage conditions with fully enclosed, dust-free systems
  • Integrate with cleanroom standards, including ISO Class 7 and higher
  • Reduce risk of cross-contamination or temperature deviation
  • Automatically log inventory movements for easy audits
  • Save floor space while scaling throughput and capacity
  • Protect high-value tools, parts, and finished goods in secure environments

With Kardex, medical device manufacturers get the reliability and control they need to focus on innovation while meeting the world's most demanding regulatory and production requirements.

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Kardex Solutions for Medical Device Manufacturers

man picking medical device parts from Kardex shuttle

Kardex Shuttle

The Kardex Shuttle vertical lift module is ideal for medical device manufacturers seeking to maximize space while improving accuracy and cleanliness. Its enclosed design protects sensitive inventory from dust and contamination, making it suitable for cleanroom integration. With automated picking and ergonomic access, it minimizes handling errors and enhances operator safety, all while supporting GMP-compliant workflows.

clean room storage for medical device parts

Clean Room Solutions

For ultra-sterile environments, cleanroom-compatible systems from Kardex are designed to meet stringent ISO classifications. These solutions use sealed access points, smooth surfaces, and non-shedding materials to prevent contamination and maintain compliance with cleanroom protocols. They’re ideal for storing surgical kits, implantable parts, and sterile packaging in environments that demand the highest hygiene standards.