Medical Device Contract Manufacturer

A global manufacturer of single-use and disposable medical devices, SMC creates complex products from concept to completion. All manufacturing facilities are FDA registered and ISO 13485 certified.

Experienced in meeting custom requirements for single use medical devices

SMC focuses exclusively on custom contract manufacturing for the healthcare market. In the medical device category, 15 of the top 30 medtech companies partner with SMC. Our experience with single patient and single use medical devices includes:

  • Surgical devices – electronic integration or mechanical function
  • Highly contoured silicone masks for hospital or home use
  • Biopsy devices
  • Laparoscopic and endoscopic devices
  • Specialty syringes/auto syringes
  • Air management

End-to-end medical device manufacturing solutions

Combining in-house engineering, injection molding and assembly expertise with our global supply chain, we provide end-to-end manufacturing capabilities, from design to distribution. Our engineering-driven, best-in-class facilities around the world provide:

Design and Development

Program Management

from design through packaging, labeling and distribution

Injection Molding

including in-house tooling and expertise in silicone, thermoplastics and micro/mini components

In-house automation and assembly

including ISO Class 7 and 8 clean rooms

Quality and Regulatory Capabilities

Rigorous program management that de-risks device manufacturing

Our customers rely on us for speed to market with high-quality products. Extensive experience in both high-volume and low-volume manufacturing informs a nuanced understanding of commercialization scale-up.


Our Program Management Process is key to risk reduction. 

A dedicated Program Manager, responsible for all communication and overall performance, including volume expectations, cost parameters and regulatory requirements, is assigned to you for the duration of the project. Depending on the project, a Subject Matter Expert—an engineering leader with highly specialized technology expertise—may provide experience and work alongside the Program Manager and others.    

A Quality Engineer is part of every project team. 

Our global quality teams operate within a robust ISO 13485-certified Quality Management System (QMS). At SMC, our complete quality and regulatory capabilities provide the assurance of electronically controlling and meeting applicable FDA and International compliance requirements. 

Supply chain quality and reliability are managed in-house. 

Our engineers and supply chain experts continuously monitor supplier metrics to ensure the supply chain is efficient, competitive, on time, and delivers high quality and value.

Automation expertise that saves time and streamlines the supply chain

At SMC, having in-house automation expertise sets us apart from other manufacturers of disposable medical devices. For low-volume manual assemblies, we can design and build automation stations in-house to complete critical assembly tasks and perform rigorous quality checks. For high-volume device solutions, our in-house automation experts work closely with established suppliers of high-speed automation systems to plan for the best method of assembly for each component.

Every program is different, and we work with our customers to determine the best plan given the technical requirements, volume, cost and timeframe.

Case Study

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