Belitsoft > FDA Cleared Software as a Medical Device (Mobile Stethoscope App) Development

FDA Cleared Software as a Medical Device (Mobile Stethoscope App) Development

Client

Our client is a Canada-based HealthTech startup, aspiring to transform global clinical outcomes by making heart condition detection and diagnosis more accessible.

Collaborating with Belitsoft's development team, the company revolutionized healthcare with the creation of their unique medical device software. This groundbreaking innovation allows smartphones to function as top-tier stethoscopes that capture heart sounds when placed against a person's chest.

Challenge

The client approached Belitsoft immediately after securing a patent for an algorithm that was supposed to become the basis for the future revolutionary mobile application.

Get FDA Clearance for the Innovative Product and Enter the Market First

The specifics of the healthcare industry is that it doesn't permit starting the development right away and simply launching software as a medical device once it's ready to go.

Legal compliance with FDA clearance is a prerequisite for marketing any Software as a Medical Device (SaMD) in Canada. The evaluation process safeguards patient safety, enhances treatment outcomes, and maintains public health standards.

Yet, the client was eager to launch the software as a medical device quickly to enter the market first with the game-changing invention to gain an edge and establish brand recognition in the healthcare industry.

These goals, while somewhat conflicting, presented a unique challenge. The meticulous preparation of documents for each feature and tool, comprehensive testing protocols, along with multiple reports and plans, presented a daunting task for the small in-house team, especially with their ambitious timeline.

The Urgent Need for a Highly Performing, Reliable Experts in HealthTech

The client's team started developing the mobile app but faced a tight deadline. They planned to showcase their product and meet with potential clients at a major innovation conference in the US.

At the same time, the development of the Software as a Medical Device (SaMD) required timely delivery of extensive documentation for FDA compliance.

To develop the SaMD within the required timeline without compromising quality, they needed to double their team size with specialists proficient in React Native, Node.js, and healthcare software development urgently.

Solution

Process

Results

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