CieloWorks

CieloWorks is a healthcare technology and Software as a Medical Device (SaMD) consulting firm specializing in custom medical software development, regulatory compliance, and quality management systems. The company provides three core service lines: Medical Software Development (custom software builds, EMR integration, system modernization), Quality Consulting (ISO 13485:2016 compliance and QMS establishment/maintenance), and Regulatory Support (FDA registration, 510(k) submission preparation, quality system audits). CieloWorks serves medical device companies, hospital R&D departments, medtech startups, clinical research organizations, and healthcare software firms. The company emphasizes specialized expertise in navigating FDA clearance processes, FHIR interoperability standards, and complex healthcare IT environments. Services span the full product lifecycle from strategic planning through market launch, with a focus on balancing innovation velocity with stringent regulatory requirements and safety standards. The firm has demonstrated experience modernizing existing platforms and integrating with major EMR systems while maintaining compliance with evolving healthcare regulations.