Hydromer, Inc. announced that its brand-new facility with extensive new capabilities is fully operational. Located in Concord, North Carolina, its new facility is a fully FDA certified, ISO9001:2015 and ISO13485:2016 approved site, designed per the latest specifications to accommodate all the Company’s functions under one roof, offering the notable services; Collaborative research and development (R&D) and manufacturing of coating formulations with production capabilities ranging from initial customer product prototype to scale-up to large quantities, including but not limited to, contract development and supply of custom coatings per customer’s needs. Coatings that can be heat or UV-cured, in solvent and water base versions to accommodate any type of coating requirements. Offering a wide range of surface modification processes such as corona, plasma treatment, solvent-cleaning and others, for difficult materials that are becoming the norm in many medical interventional devices such as microcatheters and endoluminal surgeries. Very large, modular ISO-class 8 clean room to accommodate customers’ devices of various sizes and quantities, including capabilities to coat devices up to 20-FT (600 CM) in length. Precision coating under magnification for micro-devices with strict tolerances. Expertise in coating complex devices like balloons, intricate IDs, multi-lumen and others, including emerging 3-D printed parts used in device development. Extensive analytical capabilities such as Gas Chromatography with Mass Spectroscopy (GC-MS), High Performance Liquid Chromatography (HPLC), Fourier Transmission Infra-Red (FTIR), Spectrophotometers, Contact Angle, Ultra-High resolution video scanning microscope, and other specialized scientific instrumentation. Extensive testing capabilities, including American Society for Testing and Materials (ASTM), International Organization for Standardization (ISO), The Conformitè Europëenne (CE) and Other standardized methods for friction/pinch force, abrasion resistance, light transmittance, hardness, adhesion, surface tension and others. Customized coating equipment design services developed in-house and tailored to meet customers’ specific needs. Quality Assurance offering OQ & PQ validations for customer devices, both new and innovative devices, as well as reprocessed devices, to ensure customer requirements are met.