SpecialTeamLogo

Contract Cleanroom Assembly and Packaging

Flags
Phone : (714) 694-0348
E-mail : Info@SpecialTeam.com

An ISO and FDA Registered Facility: ISO 13485:2003 | FDA Registered 2032092

Turnkey Contract Manufacturing | Industries Served

Who We Are

SpecialTeam began operations on September 1, 1996. It was formed by a proven management team from the medical manufacturing industry. We occupy a 10,000 square foot facility in Yorba Business Park One at 22445 E. La Palma Ave., Yorba Linda, California. This location contains approximately 2000 square feet of certified cleanroom manufacturing with additional space for expansion suited to customer requirements. Our cleanrooms are compliant with ISO 14644-2: 2000 and ISO 14644-3. We have excellent medical molding / manufacturing, sterilization and testing facilities, and we are centrally located to area freeways.

What We Do

SpecialTeam is a contract manufacturer of medical devices. We provide complete turnkey services, which include: Cleaning, Assembly, Packaging and contract Sterilization, Validation, and Testing of medical devices and components. Our business model is to perform these services to the customer’s specification in a controlled and verified process to meet the customer’s quality standards as well as our Quality System based on ISO 13485:2003 and ISO 9001:2008.

Clients can rely on us to perform all activities required to introduce their products to market, including procuring materials/goods/services from established supplier networks to drop shipping your product. We work hard to ensure that the purchasing or acquiring of materials is at the right quantity, superior quality and the best price.

We offer quick turnaround on the following services:

  • Procurement
  • Assembly
  • Packaging
  • Tyvek pouch and bag sealing
  • Tray sealing
  • Sterilization
  • Validation
  • Final packaging for shipping

Our experience also includes sterile product design, production facility and clean room design and medical injection molded products.

Who We Serve

SpecialTeam was designed to service primarily start-up and mid-size companies. Over the years we have had the pleasure of working with dozens of start-ups and numerous other companies of varying sizes. Every SpecialTeam client has equal access to our resources, services, and staff.

REQUEST A FREE CONSULTATION

*
*
*
...
Overflow

SpecialTeam has 5 certified Class 1,000 (ISO Class 6) cleanroom suites and an experienced staff ready to assist with your stressful production demands. Our 18 years of experience gives us the ability to efficiently manage our resources and get your product to you quickly without compromising quality.

Traceability

We operate within regulated markets and services, meaning that all our services adhere to industry standards and required certification. We offer complete product traceability with thorough knowledge and adherence to FDA, CGMP/QSR and ISO 13485:2003 & ISO 9001:2008 requirements.

StartUps

SpecialTeam recognizes the uniqueness of every device - from those needed for minimally invasive surgery to implants. We can assist you with creative designs and processes to produce solutions that are cost-effective, while developing innovative and efficient systems for packaging and assembling even the most complicated medical devices and kits.

Quality

Having our products made in the United States of America, we can ensure a rigorous quality control system for high quality products. All our services adhere to strict US regulations and standards.