Medical Contract Manufacturing and Custom Device Assembly

At SMC, the complex business of medical device manufacturing and assembly is our specialty. For each custom medical manufacturing program, we work closely with the customer to understand volume expectations, cost parameters, and device regulatory requirements. Our people and our processes deliver results that have helped us build strong relationships with many leading medtech and pharma companies during our 35+ year history.

From Development to Commercialization

Because we work exclusively in the healthcare space, we are able to meet your needs for high-volume or low-volume manufacturing. Utilizing our strengths in molding, assembly and automation, our approach allows us to efficiently scale up volume as the device moves from development to clinical trials to full commercialization.

NC Fill Finish Line


Complete Medical Device Contract Manufacturing Capabilities

Working closely with you, our team will establish a manufacturing plan for every device component and every step, from micro molded parts to highly automated in-house assembly. Teams are led by a program manager and include engineers who are experts in development, manufacturing, quality and automation, along with supply chain professionals.

Early-Stage Involvement

  • Design for Manufacturability and Assembly
  • Prototyping and Proof of Concept
  • Process Development


  • Rigorous Program Management
  • Global Supply Chain and Facilities
  • Custom Tooling and Automation

Supply Chain Management

  • In-House Global Supply Team
  • Robust Resource Planning Systems
  • Continuous Monitoring of Supplier Metrics

Quality & Compliance

  • Advanced Quality Planning
  • ISO 13485 Certification
  • FDA 21 CFR Part 4 Compliance

Pharma Services

  • Early-Stage Development and Analysis
  • Sterile Fill Finish
  • Complete Packaging Services

Sterile Filling

  • State-of-the-Art cGMP Facility
  • Small Batch Capabilities for Clinical Trials
  • Cartridges, Syringes, Vials and Custom Containers


Custom Medical Manufacturing Solutions

SMC provides full-service medical manufacturing for the pharmaceutical, medtech and diagnostics markets. Our focus is on single-use and single-patient finished devices. With our long history of quality and our partnerships with leading companies in all three markets, we understand the complex medical manufacturing ecosystem.


Find out about our combination product expertise.


Find out about our extensive in-house capabilities.


Find out about our experience with diagnostic devices.


We Measure Our Success By Your Success

As strategic partners for customers like you, our purpose is to make sure that your innovations are manufactured efficiently, at scale, and that they go to market rapidly, in full compliance with quality and regulatory standards. To make sure that plans are executable and execution goes as planned, we maintain close control over manufacturing with our extensive in-house capabilities. Our best-in-class facilities are ISO 13485, FDA registered, Part 4 compliant, Bio Level 2 certified and CGMP/QSR compliant. As a privately owned, global company, we pride ourselves on the ability to pivot quickly to meet your needs.


Efficiency and risk reduction start here, with detailed planning and DFM expertise.


In-house capabilities include injection molding and tool design and build.


In-house capabilities include injection molding and tool design and build.


Complete capabilities include labeling, kitting, boxing and shipping.


Explore Contact Manufacturing Case Studies

How can we help you succeed at every stage of your project? Let's get started!