Comprehensive Consulting Services Advancing Software as a Medical Device (SaMD) and Healthcare Technology
Our industry-centric consultants and developers drive innovation while ensuring the highest standards.
Proven Services and Expert Guidance for Unmatched Results
Our highly skilled team of consultants craft customized growth strategies and deliver top-tier solutions that meet evolving regulatory standards.
Medical Software Development
We build custom software, modernize existing systems, and enhance functionality.
Quality
Consulting
We outline, establish, and drive IEC 62304-compliant quality management systems.
Regulatory
Support
Simplify Your Path to Custom Medical Software Solutions
Aligning software development with evolving regulatory standards can be daunting. You need strategic consultants and developers who not only excel in software but also specialize in the intricate requirements of healthcare regulations.
Ready to move from research to real-world solutions?
Partner with our experts to develop cutting-edge solutions, stay competitive, mitigate risk, and meet mission-critical timelines.
Limited experience in SaMD and QMS threatening go-to-market timelines?
Depend on our experts to establish and maintain a robust QMS and manage the software development lifecycle effectively.
Meeting medical device standards proving to be taxing?
Turn to our regulatory experts to navigate complex processes and ensure your solution meets the strict standards to obtain and sustain compliance.
Streamline Processes While Driving Business Growth
Turn to our team of expert consultants dedicated to your success every step of the way. We believe in a holistic approach that consists of a strategic combination of deep industry expertise, cutting-edge technology, and proven methodologies.
Drive business growth through strategic partnerships and market expansion. Our expert consultants will share best practices and impactful strategies that will help you balance the need for cutting-edge solutions with financial constraints.
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. By integrating AI and analytics, we deliver solutions that improve diagnosis accuracy and patient outcomes.
Get your solution to market sooner while ensuring full compliance, saving you time and money while reducing risk. Our team will help you build next-level solutions while navigating complex processes with ease, maximizing efficiency every step of the way.
Simplify FDA compliance and clearance while ensuring all solutions meet regulatory and security standards. Our fine-tuned software development skills and proven frameworks will ensure your products maintain the highest safety and effectiveness standards.
Our Results
Hear from our clients
“CieloWorks has been instrumental in modernizing our software and delivering a state-of-the-art solution. The team’s innovation, programming talent, and continued responsiveness ensured the success of this project.”
Josh Penrod
SVP and Head of Global Plasma and Technical Advocacy
PPTA
Bring in the Right Expertise with CieloWorks: Highly Specialized Healthcare Tech and Software as a Medical Device Experts
Medical 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 software as a medical device 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
Proven Services from Concept to Launch
From formulating strategic initiatives to full-scale development, regulatory, and quality support, our consulting services are powered by seasoned professionals with deep expertise.
Partner with Us for Innovation and Excellence
Contact us today to get started.