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28th February 2024

Revolutionizing Healthcare: Lapsi Health’s Sound-Based Technology earns ISO 13485 Seal of Excellence

Lapsi Health announces their ISO 13485 | Medical Device Quality certification.

Innovative Dutch healthtech startup, Lapsi Health, has achieved a significant milestone by obtaining ISO 13485 certification, marking its commitment to the highest standards of medical device quality management. This milestone is proof of Lapsi Health’s dedication to delivering safe and effective healthtech solutions that meet the strictest requirements in the healthcare industry.

Founded in 2022, Lapsi Health’s technology will pioneer in transforming the conventional usage of auscultatory sounds in medicine into Digital Biomarkers, a mission that will impact millions of lives at the Point-of-Care and in remote healthcare. Achieving ISO 13485 certification demonstrates Lapsi Health’s ability to consistently meet regulatory requirements and customer expectations in the design, development, production, and delivery of medical devices.

The company is a venture backed Healthtech startup, their Seed round was led by Modi Ventures in January 2023 and is headquartered in Amsterdam, They have also established a significant presence in Helsinki, where they run their hardware development. Jhonatan Bringas Dimitriades, CEO at Lapsi Health, said: “We have been able to achieve completion in the development of our core technology, this means we are ready to establish our presence as a developer of high quality healthcare technology. By obtaining this certification, we place our company in the category of cutting-edge, successful medical tech companies”.

In the last months, the company has welcomed to their Advisory Board, additional healthcare world leaders such as Geeta Nayyar, Fabia Tetteroo-Bueno, Junaid Bajwa, and Greg Englehardtt. “These luminaries will help guide our company through our current development and into our commercialization phase,” adds Seamus Holohan, COO at Lapsi Health.

Lapsi Health’s achievement of ISO 13485 certification is not just a testament to its commitment to quality and safety but also a crucial step towards realizing its vision of making a positive impact on healthcare delivery worldwide. As the company continues to develop and deploy its innovative solutions, the ISO 13485 certification will undoubtedly play a pivotal role in facilitating regulatory approvals and fostering trust among healthcare professionals, patients, and stakeholders across the healthcare ecosystem.

For more information about Lapsi Health and its innovative solutions, visit


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