For over 30 years, Busse has offered our customer’s high quality plastic injection molded medical devices. But our experience is not limited to medical devices only; our personnel and equipment are capable of designing and creating any part that comes to mind.
- Contract Manufacturing
- Product Design & Development
- Mold Design Services
- Plastic Injection Molding
- Medical Injection Molding
Getting marketing clearance for your medical device can be a great challenge, especially without the assistance of an established expert. Having to coordinate with a myriad of regulatory agencies—each with its own requirements, regulations, and guidance—can make approval a lengthy process.
Working with a team that has traveled this road before will significantly improve your chances of success. That’s why Busse offers medical device companies the following services to expedite the regulatory process:
Finding comprehensive medical packaging services is critical to your company’s supply chain. There’s nothing more frustrating than missing a delivery deadline because of equipment limitations. You depend on your medical packaging services partner to ensure assembly on time, every time.
- Plastic Tray Fabrication
- Pouch Sealing
- Form, Fill & Seal machinery
- Kit assembly (kitting)
- Instrument assembly
- Temperature & time sensitive materials handling
- Tubing sets (cutting & fitting assembly)
- In-process Inspection
- Final Process inspection
At Long Island Sterilization, we always look for ways to save you time and money, one of the ways we do this is by consolidating or combining our testing requirements based on your family of products. Our technical specialists partner with you to develop a cost-effective program, applying over 30 years’ experience in medical device safety and regulatory compliance for your success. LIS prides itself on strict adherence to all AAMI and ISO sterilization standards.
Long Island Sterilization laboratory services includes but are not limited to the following:
- Environmental Testing
- Pyrogen Testing
- Bioburden Testing
- Setting up new facilities
- Protocols Development
- Sterilization Validation
- Environmental Monitoring
- Packaging Validation and Shelf Life Testing
- Transportation Simulation Testing
- ETO sterilization programs and cycle development
- Protocol Development Assistance
Private labeling can add new or complementary products to your product line. At Busse we understand the critical importance of speed-to-market and we have over 40 years of experience paving the way from concept to customer. With all the design, manufacturing, regulatory and fulfillment infrastructure in place, we can move your product to market at record speed while maintaining our extremely high standards of quality.
Long Island Sterilization is owned by Busse Hospital Disposables and has been in operation since 2001 in Hauppauge, New York. We are conveniently located just a few miles from the Long Island Expressway thus offering easy access and transportation for your products.
LIS maintains and operates a complete quality assurance system as per cGMP and FDA guidelines. Long Island Sterilization complies with ISO 11135:2014 and ISO 10993-7.
Busse understands that in today’s health care environment there is often a need to customize. If you don’t see what you need within our standard line of trays, we can custom design any tray to match your facility’s protocols and requirements. You can even specify the sequential packing of the components for proper aseptic technique and maximum efficiency. Take a look at our literature to see the large variety of custom kits and trays we offer.
Benefits of Busse’s custom kits and trays:
- Designed and manufactured to your specifications
- Minimize procedure set-up time and helps standardize technique
- Fast turnaround time for price quotes and samples, both sterile and non-sterile
- In-house manufacturing and sterilization reduces lead time and guarantees the highest quality
- Responsive, knowledgeable and dedicated sales team to guide you.
- Many standard tray style configurations available
At Busse, we are kit packers ourselves so we fully understand the product issues you face on a daily basis. We process orders quickly and accurately, expedite shipments, and maintain exceptional quality assurance levels. We are always adding to our OEM product listing. If you don’t see what you need, please contact our OEM Coordinator to assist you further at (800) 645-6526.
Busses’ OEM division offers the following services:
- Injection & Insert Molding
- Product & Packaging Engineering, Regulatory Assistance or complete turn-key product introduction
- Custom Sterile Procedural Trays
- Private Label Packaging & Sterilization
- Pad Printing
- Radio Frequency Assembly
- Drape Fabrication
- Facilities, resources & experience to provide the very finest in medical device manufacturing.