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

We simplify and streamline FDA registration, ensure 510(k) compliance, and prepare for audits.

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?

Delivering high-quality products on time/budget, while complying with strict standards requires specialized expertise.

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?

Creating a comprehensive QMS is demanding due to the intricate, evolving nature of regulations, requiring ongoing monitoring, updates, and audits.

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?

Ensuring products meet stringent healthcare regulations/510K compliance is time-consuming, complex, and prone to human error.

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.

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