CieloWorks provided specialized expertise and process-oriented support to Intelliguard to achieve FDA certification and complete its audit with no findings.
Published
Signal category
Legal & Regulatory
Quote
“Intelliguard achieved FDA certification and completed its audit with no findings”
— CieloWorks team
Company
CieloWorks
Comprehensive Consulting Services Spanning the SaMD and Healthcare Technology Lifecycle
- Industry
- Information Technology & Services
- Location
- Austin, US
- Company size
- 5 employees
Committed to driving innovation while ensuring the highest standards, CieloWorks’ dedicated team of medical device and healthcare technology experts specializes in crafting customized growth strategies, developing cutting-edge software, establishing robust quality management systems, and streamlining rigorous compliance processes. Backed by years of experience and focused on long-term success, clients rely on CieloWorks to implement best practices, deliver high-quality solutions to market, and foster ongoing excellence and efficiency. OUR SERVICES >> 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. CONTACT US TODAY Partner with Us for Innovation and Excellence Contact us today to get started. cieloworks.com
Founded 2021