BlackHägen Design is a multidisciplinary, usability engineering and product design firm supporting start-ups through Fortune 100 companies. Our pragmatic approach to product design is well suited to safety-critical and environmentally challenging industries, and we have produced award-winning designs for many of those clients. At our core, user-centered design 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 over 100 patents and trade secrets for nearly three 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 21CFR 820 (FDA) and ISO 13485 and is easily adaptable to our clients’ in-house QMS for seamless documentation transfer.