Sunrise Respiratory Care is a Southern California retailer that offers a full spectrum of home-based durable medical equipment, medical supplies, and respiratory care services. We are a company founded by physicians specializing in pulmonary and sleep medicine along with experienced respiratory care therapists in order to provide knowledgeable and comprehensive home-based respiratory care. We specialize in continuous positive airway pressure (CPAP/BiPAP) systems for patients experiencing a variety of sleep apnea syndromes and other respiratory related ailments. Additionally, we offer a complete line of sleep apnea treatments including PAP systems, humidification, supplemental oxygen, masks, and accessories.
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I enjoy the challenge of aligning the research, regulatory, quality systems, clinical and marketing plans with the shared goal of delivering to the marketplace validated products that benefit both the patient and the clinician. * 25 years of experience in FDA regulated industry (medical devices and in vitro diagnostics). * Domestic and international regulatory compliance submissions. * Classification, conformity assessment and technical documentation. * Broad experience with multiple FDA product classifications: cardiovascular, nuclear medicine, general surgery and orthopedic medical devices; clinical chemistry, microbiology, immunology and hematology devices in a variety of formats (IHC, ELISA, IFA, lateral flow, genotyping). * ISO 13485 * FDA 510k * 21 CFR 820
