Nutek Bravo
Medical Devices - Hayward, California, United States
Nutek Bravo Details
Nutek Bravo is being established as a Bay Area business to provide both convenient and accessible electron beam sterilization services, primarily geared for the medical device manufacturing market.Nutek Bravo's two core competencies are what any client in the health care space should value in a contract sterilizer: highly regulated sterilization-validation studies for products (per ISO 13485 and 11137) and subsequent batch processing of said products. Our mission is to work with any potential client that comes to our door--no matter if they are a big industry player or a small startup--on whatever situation the client needs to overcome using our know-how and throughput capacity. In terms of studies that can be conducted for clients, Nutek Bravo will have ISO certified protocols for establishing bioburden, maximum acceptable doses, sterilization dose substantiation, dose mapping, and sterilization dose audits. Additionally, Nutek Bravo provides a suite of non-ISO studies and consulting to assist in clients' R&D needs; the types of structured experiments that our quality team has designed can greatly assist any client's engineering department in both product and packaging development.The system of machines and technology that we employ is itself a veteran of this industry, having processed thousands of product-lines and experiments for various clients over the years. Our new facility is equipped with cold-storage (refrigerator and freezer) units to accommodate temperature-sensitive products, as well as secure storage options for controlled items. Nutek Bravo's facility is setup to meet the needs of most industry clients, but what we are known for is our quick turnaround times on batch processing orders and giving smaller medical device manufacturers access to quality e-beam sterilization services that may otherwise not be readily available in this market environment.Nutek Bravo will open our new Hayward facility, with ISO certifications, in mid-2019.
Nutek Bravo Technologies
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