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
from design through packaging, labeling and distribution
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.
How can we help you suceed?
Let's start the conversation.