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Rely on BlackHägen Design when you need specialized experience, focused design and critical resources. We have a seasoned team of engineers, designers, technical and regulatory experts with precise competency in all areas of the regulated design process. Our Quality Management System is ISO 13485 and 21CFR820-compliant and audited by top medical device firms. We can manage and submit your Design History Files through 510(K) clearance, and we can likely help you bring your project to market more rapidly than via internal resources. Our commitment to our clients and your project goals always comes first.