Ensuring Regulatory Compliance and Speedy FDA Approval for a Smart Insulin Pump

About Our Client

A mid-sized medical device manufacturer is developing a next-generation smart insulin pump designed to improve glycemic control for diabetes patients. The client needed a software development partner experienced in FDA regulatory processes to accelerate time-to-market while ensuring full compliance with stringent medical device software standards.

Facing tight deadlines and rigorous documentation requirements, they sought a trusted collaborator to handle embedded software development, quality assurance, and regulatory submissions.

Challenge

• Develop firmware and embedded software with real-time insulin delivery control
• Ensure compliance with FDA guidelines, including IEC 62304 and ISO 14971 risk management
• Prepare comprehensive documentation for FDA 510(k) premarket notification
• Integrate cloud connectivity features for remote monitoring and data analytics
• Meet tight project deadlines without compromising quality or safety

Solution

Celestial Infosoft assembled a dedicated cross-functional team skilled in embedded systems, regulatory compliance, and cloud integration. We adopted a risk-based software development lifecycle adhering strictly to IEC 62304 and ISO 14971 standards.

Our engineers developed reliable, fail-safe firmware in C/C++ on Embedded Linux, incorporating rigorous testing and validation protocols. Cloud services were implemented on AWS for secure data storage and remote device management.

We guided the client through FDA documentation, creating detailed Design History Files (DHF), risk management plans, and validation reports to support the 510(k) submission.

Project Highlights

• Delivered high-integrity embedded firmware, ensuring precise insulin dosing
• Implemented secure cloud connectivity with encrypted data transfer
• Achieved full IEC 62304 compliance with comprehensive risk mitigation strategies
• Produced exhaustive FDA submission documentation, expediting regulatory review
• Maintained agile communication for rapid issue resolution and milestone delivery

Results

• FDA 510(k) clearance granted within 6 months of submission
• Accelerated product launch by 4 months compared to the industry average
• Enhanced patient safety with robust fail-safe mechanisms and alerts
• Enabled remote monitoring capabilities, improving patient adherence and outcomes
• Positioned the client for competitive advantage in the smart insulin pump market

Technologies and Tools

• Embedded Software: C/C++, Embedded Linux
• Cloud & DevOps: AWS, Azure DevOps, Jira
• Database: PostgreSQL
• Compliance: IEC 62304, ISO 14971, FDA 510(k) documentation

Client Feedback

“Celestial Infosoft’s expertise in medical device software development and regulatory compliance was key to our successful FDA approval. Their proactive approach and attention to detail ensured a smooth submission and accelerated our time to market.”

– Client Says