Klaris raises $1M to address regulatory challenges in medtech

London-based medtech startup Klaris has secured $1 million in pre-seed funding to automate regulatory compliance for medical device manufacturers. This investment, led by Meridian Health Ventures and supported by notable healthcare institutions and angel investors, highlights the growing need for efficient solutions in a complex and expanding market. The funding will be instrumental in expanding Klaris's team and accelerating its commercial growth, particularly within the European Union. The global medical device market is poised for significant expansion, projected to surpass $1.1 trillion by 2034. However, bringing new devices to market is hindered by stringent regulatory hurdles, with a substantial percentage of submissions facing rejections due to quality deficiencies. In Europe, evolving regulations like the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are impacting research and development and potentially reducing the availability of devices on the market. Klaris addresses these challenges with an AI-powered software platform designed to streamline the compliance process for medical device companies. The platform automates consistency checks and gap identification within technical documentation, ensuring alignment with regulatory requirements and preparing manufacturers for crucial submissions and audits. By integrating AI-driven analysis with validated regulatory frameworks, Klaris aims to revolutionize traditionally manual documentation workflows, enhancing traceability, data security, and overall efficiency throughout the product lifecycle, fostering greater digital sovereignty in a critical sector.