Sterling Industries is a vertically integrated contract manufacturer of medical devices and medical device components with facilities in both the US and Canada.  We help companies — from Fortune 100 to mid-size to start-up — scale from launch to full production (whether it be from thousands to millions of units), with consistent and immaculate quality, process and compliance.  We offer a repeatable design transfer process, design-for-manufacturing expertise, regulatory compliance and supply chain optimization.  Our company mantra is: 100% on time, 100% complete and 100% quality.  We manufacture success.

Whether your device requires complicated machined components, intricate injection molded parts, laser cut small diameter stainless steel tubing, laser cut large format metal, robotically welded pieces, integrated electronics, ultrasonic welded parts, and/or low pressure over-molding, our team of engineers, designers and technicians can help make your product a reality.  We assemble your device in a Class 7 Clean Room, a White Room or on the Shop Floor as required.

We are ISO 13485:2016 Certified and 21 CFR Part 820 Compliant and are FDA and Health Canada Registered.  Let’s discuss your project.  Contact us by email at sales@sterlingindustries.com or call us toll-free at 1 (888) 669-0246.

Manufacturing

Medical Devices

Sterling Industries

Sterling Industries' headquarters in Woodbridge, Canada

This department ensures that products meet set standards of quality through testing and evaluation.

Quality Assurance

The Quality Assurance Team at Sterling Industries is responsible for ensuring that all medical devices and components meet the highest standards of quality, compliance, and safety. This team conducts rigorous inspections, testing, and validation processes across all production stages, from design transfer to full-scale manufacturing. They ensure adherence to ISO 13485:2016 standards and 21 CFR Part 820 regulations, while also managing regulatory requirements for FDA and Health Canada registration. Through meticulous quality control, they uphold the company's commitment to delivering 100% on-time, complete, and defect-free products.

Quality Assurance Team

The Engineering team at Sterling Industries is responsible for the design and development of medical devices and components, ensuring they meet stringent regulatory and quality standards. They work collaboratively to transition products from initial concept through to full-scale production, employing advanced engineering techniques such as precision machining, injection molding, and robotic welding. Their focus on design-for-manufacturing and process optimization allows Sterling Industries to deliver high-quality, compliant products on time and at scale.

Engineering

This department focuses on engineering design and process development to innovate and enhance product solutions.

Design and Development

This department focuses on the design, development, and testing of mechanical systems and components.

Mechanical Engineering

This department oversees and coordinates operational processes to ensure efficiency and effectiveness across the organization.

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Other teams

Quality Assurance Team

Engineering

Design and Development

Mechanical Engineering

Operations Management