# Sterling Industries: Medical Devices Contract Manufacturing

> Sterling Industries is a medical device contract manufacturer with facilities in the US and Canada. We provide end-to-end medical device manufacturing and design solutions.

## About Sterling Industries

Sterling Industries specializes in contract manufacturing for Class I, II, and III medical devices. We operate ISO 13485 certified facilities in both the United States and Canada, offering complete manufacturing solutions from initial design through commercial production. Our contract manufacturing services include design and development, manufacturing, injection molding, assembly, supply chain management, sterilization management, packaging and labeling, and logistics.

We serve a wide range of medical device companies. Medical device contract design and manufacturing is our only focus. We manufacture single-use sterilized products, complex endoscopes and imaging devices, OR and ICU equipment, patient safety solutions, sensors and test kits, aesthetic instruments, and wearable devices. Every engineer, every process, and every decision on your project is shaped by deep industry knowledge. You work with a team that understands the stakes.

## Core Capabilities

**Manufacturing Services:** Injection molding (15 to 500 ton presses), cleanroom assembly (ISO Class 7 and 8), ultrasonic welding, automated and manual assembly lines, packaging and labeling, sterilization validation (EtO and gamma)

**Regulatory & Quality:** ISO 13485 certified, FDA registered, Health Canada licensed, full design history file management, process validation, design transfer support

**Materials Expertise:** Medical grade plastics (PEEK, polycarbonate, polypropylene, ABS), silicones, stainless steel components, biocompatible materials

**Design Support:** Product design and development, prototyping, design for manufacturability, material selection, regulatory pathway guidance

## Pages

- [Home](https://www.sterlingindustries.com/): Overview of Sterling Industries and our medical device contract manufacturing services. Learn about our capabilities, facilities, certifications, and the markets we serve.

- [Design & Development](https://www.sterlingindustries.com/medical-device-design-development/): Product development services from concept through regulatory approval. We help with design optimization, prototype development, design verification testing, and manufacturing transfer.

- [Medical Device Manufacturing and Assembly Services](https://www.sterlingindustries.com/medical-device-manufacturing-assembly/): Detailed information about our end-to-end contract manufacturing and assembly services.

- [Medical Device Manufacturing Capabilities](https://www.sterlingindustries.com/medical-device-manufacturing-assembly/manufacturing-capabilities/): Detailed information about our injection molding, assembly, sterilization, and packaging capabilities. Includes equipment specifications, cleanroom classifications, and quality certifications.

- [Facilities](https://www.sterlingindustries.com/about/manufacturing-facilities/): Information about our manufacturing locations in the US and Canada. Details on facility size, cleanroom capacity, equipment, and certifications at each location.

- [Contact](https://www.sterlingindustries.com/contact/): Connect with our team to discuss your manufacturing needs. Request a quote or schedule a facility tour.

- [Privacy Policy](https://www.sterlingindustries.com/privacy-policy/)

## Posts

- [How to Find the Right Medical Device Contract Manufacturer](https://www.sterlingindustries.com/2025/11/20/how-to-find-the-right-medical-device-contract-manufacturer/): Your medical device works. You've been through development, testing, and regulatory approval. You understand the market opportunity, and now you need a medical device contract manufacturing partner to help you with commercialization.

- [When to Partner with a Medical Device Contract Manufacturer | LSI USA '25](https://www.sterlingindustries.com/2025/10/16/when-to-partner-with-a-medical-device-contract-manufacturer-lsi-usa-25/): Insights on timing and considerations when selecting a manufacturing partner during different stages of product development.

- [Sterling Industries Receives EcoVadis Committed Badge](https://www.sterlingindustries.com/2025/08/13/sterling-industries-receives-ecovadis-committed-badge/): Recognition of our commitment to sustainable manufacturing practices and environmental responsibility.

## Key Information for Prospects

**Minimum Order Quantities:** We work with both prototype runs and commercial production volumes. Contact us to discuss your specific project requirements.

**Lead Times:** Typical lead times vary by project complexity. Production runs depend on volume and complexity.

**Facility Locations:** Primary manufacturing in both the United States and Canada. Both facilities maintain ISO 13485 certification and FDA registration.

**Products We Manufacture:** Single-use sterilized products, complex endoscopes and imaging devices, OR and ICU equipment, patient safety solutions, sensors and test kits, aesthetic instruments, and wearable devices.

**Certifications:** ISO 13485, FDA registered, Health Canada licensed, EcoVadis Committed Badge

## Optional

- [Sitemap index](https://www.sterlingindustries.com/sitemap_index.xml)