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Medical Device Software Quality Innovation

HTD experts have industry knowledge and experience to seamlessly deliver SaMD products that meet regulatory requirements, deliver value to their users, and save patients' lives. Avoid medical device software development mistakes and accelerate innovation while decreasing cost and time to market with HTD

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Unlock SaMD Success: From ideation to FDA submission

HTD is your trusted partner in medical device software development, with ISO 13485 certification that underscores our commitment to quality management and ISO 27001 certification that ensures top-tier security. We specialize in navigating the highly regulated Software as a Medical Device (SaMD) space, incorporating best practices in compliance with IEC 62304 for software development and ISO 14971 for risk management. Our expert teams support you throughout the entire product life cycle: from product development to risk classification, usability engineering, quality advisory, Design Control Management, and compliant agile development, while also providing FDA guidance. Let us help you bring your innovative medical software to market with confidence, compliance, and speed. We empower you to accelerate innovation by delivering life-saving SaMD products.

Let's work together on:

  • Build in Agile way that i compliant with IEC 62304 to ensure your device is safe and will be on the market in no time!

  • Design patient-facing software experiences that drive change to boost engagement & improve lives.

  • Strategize wisely ensuring adherence to 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 and minimize errors while improving experiences.

  • Set up and manage medical device design controls with full traceability to ensure compliance while using our robust eQMS

  • Ensure robust cybersecurity measures and data protection as our utmost priority.

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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