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Predictable results are a significant factor when considering outsourcing. In manufacturing, the last things you need are surprises or unpredictability. A reliable and dependable manufacturing partner can be one of your greatest assets, freeing up in-house resources and increasing your ability to deliver consistent results to your customers. As a highly specialized contract manufacturer, we develop processes that are efficient, reliable, and offer cost savings. We perform regular testing and reporting to ensure that you have a clear view of the manufacturing process and the quality of your product. Initialization We work to clearly understand your technical, design, performance, economic, and intellectual property goals and requirements. We share best practices and clearly explain options and benefits of different manufacturing approaches, and chemistry products. Incoming Inspection Following a previously agreed upon inspection plan, we will receive, document and warehouse each incoming lot of materials. Coating Services From surface preparation to device fixturing, coating and curing, our skilled technicians deliver results. Inspection and Quality Based on the quality plan for your product, we inspect and test for a variety of parameters including surface coverage, coating thickness, lubricity, and durability. Final Assembly We can perform a variety of secondary operations after the coating process to reduce time-to-market and to uphold the quality of your product. Capabilities include:
Packaging We can assist in all aspects of packaging selection and utilize vendors who deliver quality materials, on time and at reasonable prices. Harland will arrange D.O.T. approved transit testing for your product as requested. Sterilization Services We coordinate all aspects of sterilization including sterilization validations quarterly dose audits, annual ETO re-qualifications and routine processing. We use only ISO certified processors and provide certificates of processing with each shipment. We can help you select materials for your products which will allow you to use a preferred method of sterilization. Warehousing and Delivery We provide warehousing solutions for coated sub-assemblies or finished products, allowing you to manage your inventory off-site so you can devote your own space to what you do best. We can even work with you to coordinate shipments to your end users. Documentation We establish and implement written procedures to ensure that device history records are maintained in accordance with the Device Master Record (DMR) including information on incoming material acceptance, the manufacturing process, dates of manufacture, quantities manufactured, quantities released for distribution and acceptance records. |

