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Firmware & Software Development
We develop end-to-end firmware and software development aligned with IEC 62304 and SDLC best practices. Our expertise includes embedded systems, cloud integration, SaMD, automated unit testing, and comprehensive software documentation to support regulatory submissions.
Quality & Regulatory Support
We provide end-to-end Quality & Regulatory support aligned with FDA 21 CFR Part 820, CE marking requirements, and global standards. From FDA submissions and Gap Analysis to CAPA, Risk Management, and Post-market Surveillance, our expertise ensures timely, audit-ready compliance.
Digital Health Solutions Services
Review Our Case Studies
Hear From Our Clients
"Neuroglee had the pleasure of working with DHS on a business-critical project aimed at achieving ISO 13485 certification. DHS played a crucial role in setting up our eQMS and implementing effective design controls, which streamlined our development processes. Their extensive knowledge of IEC 62304 compliance requirements ensured our software met the highest industry standards for safety and effectiveness.
Additionally, their guidance in developing the Design History Folder and their expertise in quality and regulatory processes were instrumental in our successful certification."
Aniket Singh Rajput
Founder & CEO, Neuroglee Health
Hear From Our Clients
"DHS has proven to be an indispensable partner in our journey towards FDA approval. Their hands-on, well organized, and adaptable approach has streamlined our documentation process, and their subject matter expertise has proved to be invaluable. DHS’s proficiency in their field has greatly contributed to our success. We are very pleased with the results they’ve delivered."
Mike Sampson
Chief Commercial Officer, NanoDx
Hear From Our Clients
"DHS was invaluable to our team in the development of the DHF for our SaMD. The DHS technical team provided guidance in all elements of design controls, including serving as independent reviewer in code review design reviews. We found the DHS team to be knowledgeable and easy to work with, along all levels of experience in our organization. That went from new-to-medtech commercial software developers to experienced (though less so in SaMD) medical device professionals. Another major factor in my recommendation of DHS is their command of the ever-changing FDA Guidances on software, cybersecurity in particular."
Matt Garrtiy
Director of Quality, Riva Health
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