Success in the medtech and life sciences market requires juggling technological innovations, changing regulations, and getting new products on the market quickly while maintaining aging products and developing next-generation designs of successful products.
ALTEN Technology supports our partners’ success in the medtech and life sciences space by specializing in rapid product development while meeting strict requirements for quality, safety, and reliability. Our Denver, Colorado, delivery center focuses on FDA-regulated (and peripheral) products and has a quality management system certified to ISO 13485 to fully serve our medtech and life sciences clients.
Our experience working on complex class II electromechanical medical devices ranges from low-cost, disposable wearables to free-standing diagnostic instruments. From conceptualization through transfer to production planning for 510(k), we’re focused on helping you meet your specific goals while identifying and mitigating risk throughout the program and product life cycle.