Medical Device Embedded Software Development — IEC 62304 & FDA Compliant

We follow a 'compliance-by-design' approach. Our software development life cycle is modeled after IEC 62304, with rigorous documentation, risk management, and verification at every stage.

Absolutely. Our team specializes in form factor optimization and component selection to create ultra-thin and small designs without compromising performance.

Yes, we offer complete product lifecycle support, including post-launch maintenance, feature enhancements, and managing component obsolescence.

We implement a multi-layered security strategy, including secure boot, data encryption, secure OTA updates, and robust cloud security protocols.

We have implemented AI/ML algorithms both at the edge (on the device) for real-time analysis and in the cloud for large-scale data processing and predictive analytics.

Yes, we offer flexible engagement models. We can act as your complete outsourced R&D team or augment your existing team with specialized skills.

Timelines vary based on complexity and classification. A simple wearable might take 6-9 months, while a complex diagnostic system could take 18-24 months. We can provide a detailed estimate after an initial consultation.

Yes, we have a proven track record in designing high-speed, FPGA-based medical equipment for applications requiring intensive data acquisition and processing.

Our key differentiator is our cross-domain expertise, our one-stop-shop capability covering the full product cycle, and our unwavering commitment to quality and regulatory compliance.

Yes, our value engineering services include detailed BOM analysis to identify cost-effective alternative components and reduce manufacturing costs.

It begins with a detailed discovery call to understand your vision, requirements, and challenges. We then move to a proposal stage outlining the scope, timeline, and deliverables.

While we are not a manufacturer, we provide comprehensive manufacturing support, including DFM (Design for Manufacturability) analysis, vendor selection, and production line setup guidance.

All intellectual property developed specifically for your project belongs to you. We ensure complete IP protection and confidentiality.

We follow ISO 13485 compliant quality management system processes to ensure our engineering services meet the stringent standards required for medical device development.