Drive Project Outcomes with Healthcare-Focused Regulatory, Compliance and Software Development Expertise
Get flexible solutions, including Software Development, Quality Systems, and Regulatory Consulting for SaMD and Decision Support Software.
Drive Innovation, Efficiency, and Regulatory Adherence with Scalable SaMD Expertise
From full scale development and regulatory support to strategic staff augmentation to expand capacity, get the support you need to build impactful products.
Medical Software Development
Medical Device Software (SaMD) Development
Decision Support Software (DSS) Development
Regulatory and 510(k) Support
Guided 510(k)
Retained Regulatory Services
Project-Based Regulatory Consulting
Quality
Consulting
Quality System
Implementation
Quality System Review
Bridging the Development & Regulatory Gap to Simplify Your Path to Custom Medical Software Solutions
Aligning software development with evolving regulatory standards can be challenging. You need developers who, not only excel in software, but also have experience meeting the intricate requirements of healthcare regulations. This streamlines the compliance process, ensuring that your innovations comply with regulatory expectations for 510(k) clearance from the outset.
Meeting medical device standards proving to be taxing?
Regulatory and 510(k) Support
Limited technical experience for SaMD threatening innovation?
Quality
Consulting
Ready to move from research to real-world application?
Medical Software Development
Achieve Your Patient Care Software Goals with Precision in Development and Compliance
You can confidently take your medical device software software to market with solutions that are as precise as they are reliable. At CieloWorks, your need for compliant, user-focused software development is met with industry-leading expertise and methodology.
Streamlined Regulatory Navigation
Simplify FDA compliance and clearance with development and aligned regulatory consulting. Expedite your product’s market entry while ensuring full compliance, saving you time and reducing risk.
Advanced Decision Support Systems
Enhance your clinical decision-making with cutting-edge decision support software. By integrating AI and analytics, we partner with clients to deliver solutions that improve diagnosis accuracy and patient outcomes.
Quality System Implementation
Elevate your quality assurance standards with a robust quality system. Our frameworks ensure your products consistently meet the highest safety and effectiveness standards, providing a solid foundation for trust.
User-Centric Software Design
Deliver exceptional user experiences with software designed for the needs of healthcare providers and patients. Our intuitive interfaces and accessible features are engineered to reduce complexity and enhance usability.
Cielo-Success
Hear from Our Clients
[Built] the next generation of NDDR & CDCS
“Dean and team worked enthusiastically with us to build the next generation of NDDR & CDCS, applying state-of-the-art technology that supports our industry’s deep commitment to the highest standards of donor health and safety for the future.”
CEO, PLASMA INDUSTRY LEADER
Bring in the Right Expertise with CieloWorks: Highly Specialized Medical Device Software Experts
Medical Device Software Development is not just software development. The medical context significantly raises the stakes. You need to be able to innovate and move quickly while meeting quality and regulatory standards, all with the highest level of safety and integrity. CieloWorks has built and maintained a SaMD for years and will bring the lessons learned and resulting processes to your project.
Medical Device Companies
Quality Assurance Managers
Medical Software Companies
Hospital R&D Departments
Software Engineers in Healthcare
Clinical Research Organizations
Regulatory Compliance Officers
Health IT Managers
Startup Biotech Firms
Medical Device Entrepreneurs
Startup Medtech Firms
Innovate, Build, and Comply: Your Pathway to Revolutionary Healthcare Solutions
Start at the beginning or exactly where you are. We’ll catch up and provide the necessary support to achieve your goals.
Get Support for Medical Device Software Development or 510(k) Clearance Today
We’re here to help you tackle regulatory hurdles or speed up your journey to market. Connect with us to get started.