Frequently Asked Questions


Frequently Asked Questions

Find the answers to some of our clients’ most common questions. If you have a question that is not covered below, don’t hesitate to ask — we’re happy to share our views and insights on any issue related to Medical Devices: production, design, quality, cost and regulatory compliance.

Sterling currently operates 4 manufacturing facilities in North America, covering 150,000 square feet (or 14,000 square meters). Our facilities are located in Central Michigan in the United States and Southern Ontario in Canada; our Headquarters are located within the Greater Toronto Area.
Learn more at our Facilities page.

There are numerous reasons:

  1. Supply chain security: COVID revealed just how fragile global supply chains are. By manufacturing in North America, at the heart of the world’s largest consumer and healthcare markets, transport and shipping lead times are significantly decreased, both inbound and outbound.
  2. Regulatory standards: North America has the highest quality standards and regulations in the world, something that Sterling embraces, forming part of our core identity.
  3. Innovation: North America remains at the forefront of global innovation, hosting the world’s top universities, research institutions, and technologies, giving us the ability to remain ahead of the curve and innovative

Typically, we do not design original devices “from scratch”; instead, we optimize our clients’ proprietary designs for scaled manufacturing. Sterling’s Design Transfer process captures every nuance of our clients’ original design. Then, our Design-for-Manufacturing (DFM) team offers manufacturing and assembly recommendations that can improve quality, repeatability or reduce costs when manufacturing at scale. We collaborate with our clients at every step.

OEM stands for Original Equipment Manufacturer, a type of contract manufacturing relationship wherein complete products are manufactured & assembled to exact specifications, finished and ready-to-ship, for their client. Medical Device OEMs focus specifically on manufacturing within the strict regulatory and quality frameworks that govern medical device production.

Contract manufacturer is a general term for manufacturers who are contracted to produce parts (components, sub-assemblies, etc) or complete products for their clients. Sterling is a contract manufacturer that focuses on production of complete devices, including assembly, often in an OEM relationship with clients. In some cases, we fabricate key components or sub-assemblies for our clients.

We are a North American, vertically integrated contract manufacturer and assembler of medical devices and components. We help our clients — whether Fortune 50 companies or late-stage startups or “scale-ups” — produce their products at scale by providing end-to-end manufacturing solutions based on our expertise, experience and advanced manufacturing capabilities.

Yes. Sterling Industries is registered with both the FDA in the United States and its Canadian counterpart, Health Canada.

Sterling Industries is ISO 13485:2016 registered, C-TPAT and 21 CFR Part 820 compliant, fully registered with both Health Canada and the FDA, and maintains state-of-the-art quality management systems.

Yes, we do. Sterling has facilities in both the United States and Canada, allowing us to take advantage of numerous free trade & tariff advantages. Strategic configuration of a product’s supply chain, manufacturing and assembly can provide provide our US-, Canadian- and Internationally-based clients easy, tariff-free access to key markets. Our U.S. headquarters are proudly located in Kalamazoo, Michigan, a hotspot for both medical innovation and manufacturing.

DFM stands for Design For Manufacturing, and refers to design refinements that improve the ease, speed, quality, repeatability and/or cost-effectiveness of manufacturing a given product at scale. Thoughtful DFM decisions can meaningfully impact the profitability and reliability of medical devices. Related terms include DFA (Design For Assembly) or DFMA (Design For Manufacturing and Assembly).

Sterling Industries has a wide range of advanced manufacturing and assembly capabilities ranging from

  • Class 7 (ISO 10,000) Clean Rooms,
  • advanced injection molding & low-pressure molding
  • CNC machining,
  • laser tube forming & processing
  • Metal finishing,
  • electronics integration,
  • robotic, laser, and ultrasonic welding,
  • as well as automated/robotic high-speed assembly and packaging.

You can find a list of our full capabilities on our manufacturing capabilities page.

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Process & Design

Manufacturing & Assembly

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Quality & Certification