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
ISO 13485-Compliant Quality Management System
Compliance program
21 CFR Part 820 Compliance Support
Compliance program
ISO 14971 Risk Management
Compliance program
IEC 62304 Medical Software Lifecycle Development
Compliance program
IEC 62366 Usability Engineering
Compliance program
IEC 60601 Electrical Safety
Compliance program
IEC 61010 Electrical Safety
Compliance program