BlackHägen Design is a multidisciplinary, user-research and product design firm, supporting start-ups through Fortune 50 companies. Our pragmatic approach to product design is well suited to safety-critical and environmentally challenging industries and have a long-standing history serving those clients. At our core, user-centered processes drive innovation and sustainable product development. This systematic methodology for translating research insights into design requirements and creating valuable intellectual property has contributed to more than 100 patents and trade secrets over the last two decades.
We continuously optimize the quality of our methodologies and services through rigorous deployment of our Quality Management System, which is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485, while easily adaptable to our clients' in-house QMS for seamless documentation transfer.