Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe
SMC’s exclusive focus on the healthcare market, combined with over 25 years of experience, allows us to offer expert knowledge for your finished device. As a contract manufacturer, we provide full service solutions for the medical device, pharmaceutical, and diagnostics markets. Our focus is single use and single patient devices.
With operations spanning the United States, Costa Rica, India, and the U.K., our design, program management, and manufacturing sites are positioned to serve the healthcare marketplace. SMC offers device services that range from initial design, tooling, component manufacturing, assembly, automation, full supply chain management, and kitting/packaging services for single use and disposable medical devices.
Product design and development is a driving force behind the success of every device. SMC Ltd. offers an innovative and multi-disciplinary approach to product design encompassing research, program management, product design expertise, rapid prototyping, and regulatory testing through final production. As your partner, we offer customized solutions that encompass design functionality and user interface within an aesthetic package that reflects your company brand and identity. Our dedicated teams of engineers have the knowledge and experience to transform your concepts into successful and reliable products. Whether you engage our team in a full development effort or simply employ us as an extension of your team, we are committed to a successful product introduction.
SMC offers capabilities such as:
- FDA and clinical trial expertise
- Product design and development
- DFM expertise
- Regulatory compliance
- Component manufacturing – plastic, silicone, and micro molding
- Electronics to mechanical interface
- Electronic integration for digital health
- Novel auotinjectors customized to your drug
- Knowledge of medical grade materials
- In-house supply chain management
- In-house automation design and build
- Drug handling
- Reagent filling
- Kitting and packaging
- Post sterile product handling
- Low cost country options
SMC’s facilities are ISO 13485, FDA registered, Bio Level 2 certified, and CGMP/QSR compliant. Our strength in providing validation utilizing IQ/OQ/PQ and proven regulatory compliance ensures your product repeatedly meets the required specifications. From initial design through manufacturing and delivery, our quality systems provide a high degree of assurance for your product.
The success of your program is also a measure of our success. We value long-term relationships so your SMC experience is important to us. Our reward for a job well done is being awarded your next program.
For more information contact SMC Ltd.
Automated Manufacturing Systems
By offering full scale-up solutions supporting clinical trials to finished devices requiring fully automated high-speed automation, SMC will work with you to determine your assembly needs while still keeping cost under control. The SMC team will develop a plan with you to get your device ready for c...
SMC’s exclusive focus on the healthcare market provides experience and understanding of the unique requirements and regulatory pathway for drug delivery devices from product development through combination product manufacturing. Our focus is to provide our customers with high quality and robust manufactur...
Electronic integration has been effectively used in medical devices for years, and today’s data driven environment is growing this sector significantly. The effectiveness of such devices depends on the robust design, engineering, and performance of not only the electronics themselves, but how they i...
Micro and Miniature Molding
At SMC Ltd., we understand that precision matters when it comes to micro molded medical parts. With part sizes starting at 0.003 cubic inches (0.045 grams) and smaller, we can provide even the smallest parts while still holding tight tolerances. Through our proprietary micro molding process coupled with in-ho...
Packaging, Labeling, and Kitting
Packaging, labeling, kitting, and sterilization are important considerations to be decided early in the design phase. As a contract manufacturer, SMC provides complete packaging and labeling of your device, and will coordinate the sterilization. The SMC global sourcing team is aligned with a network of gl...