At NovoSci, we are a vertically integrated solutions provider in the area of medical device contract manufacturing. We specialize in producing single-use, sterile products used in cardiovascular and general surgery. With our extensive background and qualifications, we understand that quality comes first. We work side by side with customers from pre-production through manufacturing, assembly, packaging, and worldwide distribution to get products to the market cost-effectively and on time.

Our flexible service model combined with a state of the art production facility enables us to manage programs of any volume or complexity. We are structured to fulfill low volume orders on a quick-turn basis as well as handle high volume, large scale production. Our capabilities include Class 7 cleanroom manufacturing and assembly using methods such as ultrasonic welding and adhesive bonding. Along PVC, polycarbonate, and polypropylene, we manufacture custom tubing packs using acrylic, nylon, and stainless steel. We provide customized labeling with UDI barcoding and have extensive resources for kitting and packaging in bags, pouches, and trays.

As a vertically integrated medical contract manufacturer, we deliver substantial value to the overall supply chain. We have a climate controlled warehouse with an integrated materials management system and offer order fulfillment and global distribution from our location in the Central United States.

We have a robust, ISO 13485:2016 quality assurance program, use lean manufacturing strategies and hold ourselves to very high internal standards. Along with custom manufacturing, we have a catalog of over 300 standard products, such as disposable connectors, cannula, tubing and accessory packs for use cardiac surgery and a line of adult and pediatric suction devices. All manufacturing is done in the U.S.A., and we use innovative and streamlined processes to keep costs as low as possible. To learn more about our medical device contract manufacturing services or to schedule a consultation, contact us directly.
Unit of Measure

Specifications

Manufacturing Process

N/A Assembly Bar Sealer Bonding (Adhesive) Cleanroom Manufacturing (Class 7) Comprehensive Packaging Tyvek Pouches or Trays Custom Perfusion Supply Kits Customized Labeling with Unique Device Identification (UDI) Barcoding Kitting Tubing Packs for Cardiovascular/General Surgery Ultrasonic Welding

Materials (Plastics)

N/A Polycarbonate (PC) Polypropylene (PP) Polyvinyl Chloride (PVC)

Materials

N/A Acrylic Nylon

Materials (Metal)

N/A Stainless Steel

Additional Services Provided

N/A Climate Controlled Warehousing Sterilization and Injection Molding Management Third Party Logistics Worldwide Distribution

Production Volume

N/A Blanket Orders Capable of Small to High Volume Orders High Volume Low Volume

Lead Times

N/A Emergency Services Available Quoted on Job by Job Basis Rush Services Available

Efficiency

N/A Kaizen/5S Lean Manufacturing

Certifications

N/A FDA Registered ISO 13485:2016

Additional Information

Industry Focus

N/A Manufacturing Material Handling and Processing Medical Medical Devices Packaging

Industry Standards

N/A ANSI (American National Standards Institute) CE (The CE mark (officially CE marking) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA).) FDA (Food and Drug Administration) ISO (International Organization for Standardization)

File Formats

N/A JPG or JPEG (Joint Photographic Experts Group) PDF (Portable Document Format) TIFF (Tagged Image File Format)