Since 1998, 100% employee-owned Key Tech has built its Baltimore identity around a personal, interdisciplinary approach to solving difficult product-development problems. The company helps medical technology brands and startups turn emerging technologies into practical products, carrying projects from concept through production under an ISO 13485-certified quality system.
ISO 13485 Certified
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ISO 13485-Compliant Quality Management System
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21 CFR Part 820 Compliance Support
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ISO 14971 Risk Management
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IEC 62304 Medical Software Lifecycle Development
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IEC 62366 Usability Engineering
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IEC 60601 Electrical Safety
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IEC 61010 Electrical Safety
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