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FDA Software Guidance


Expert guidance and technology services from idea to FDA submission.

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Looking for a medical device software development company?

HTD Health specializes in FDA-regulated software development, guiding organizations and innovators like you through the complex landscape of medical device software to ensure FDA clearance. Our experienced team prioritizes compliance, quality, and innovation every step of the way on your FDA regulatory pathway journey.

Unlock Success with FDA

From ideation to FDA submission, HTD supports you in navigating FDA regulatory pathway requirements with ease.

HTD is your trusted partner for creating Software as a Medical Device (SaMD) according to FDA standards. We're experts in navigating the FDA's rules for medical devices. Let us guide you in bringing your medical device software to market, while speeding up the process to get life-saving products to market faster.

How we help

  • Build using the agile framework while maintaining compliance with IEC 62304 to ensure device safety and reduce time to market.

  • Ensure success with FDA submissions, whether 510(k), De Novo, or PMA. HTD will guide you throughout the whole process to ensure success and FDA approval.

  • Learn about industry best practices and regulatory standards for optimized product quality and long-term success.

  • Follow IEC 62366-1 to optimize interactions between people and devices: minimize errors while improving user experiences.

  • Create groundbreaking AI-enabled solutions. Build software in a compliant way that meets all FDA requirements for software as medical devices (SaMD).

  • Ensure robust cybersecurity measures and data protection at every step of product design, development, deployment, and maintenance.

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We'll email you to set up a meeting.
 In the meantime, check out some relevant HTD Insights articles.

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Digital Health Principal

Weronika Michaluk

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HTD has served 100+ top companies across healthcare


Nitin Gujral

HTD's deep knowledge of healthcare and healthcare IT made them an ideal partner for developing our new mobile app. Leveraging their expertise in the most current consumer grade frameworks and technologies, we were able to accelerate our timeline and decrease project risk. We'd highly recommend HTD for any healthcare product development needs.

Nitin Gujral

Director of Software Engineering and R&D
Innovation and Digital Health Accelerator
Boston Children's Hospital