ISO 13485 Certified
We ensure compliance with medical device regulations for quality and safety.
We imagine, design, and engineer products that do more than function; they connect people, systems, and outcomes in healthcare, government, and high-impact outdoor ventures. Espiritu Studio is a design + engineering ISO 13485 certified consultancy. Our system integrates regulated medical device requirements, documentation standards, risk analysis, and quality-controlled engineering execution. We help bold thinkers turn purpose-driven ideas into real-world outcomes.