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 System

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

Without a dedicated regulatory team, developing medical software can seem challenging due to the risks and compliance demands inherent in the process. Get regulatory and development support to take your product and quality system across the finish line.

Limited technical experience for SaMD threatening innovation?


Pushing the boundaries of medical device software innovation without technical expertise to meet quality and regulatory standards can potentially slow down or stall your progress completely. Bring in the expertise to keep your project on track.

Ready to move from research to real-world application?

Medical Software Development

Closing the gap between developing cutting-edge medical devices and clinical adoption hinges on your ability to ensure that your software is reliable and meets all safety and quality standards. Partner with experts to mitigate risk and smooth your transition.

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.


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.”


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 X 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.