According to a recent LinkedIn post from Koios Care, the company has achieved ISO 13485:2016 certification for its quality management system. The post links this certification to its work in artificial intelligence and Software as a Medical Device, particularly for Parkinson’s disease management.
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The company’s LinkedIn post highlights that the certification covers processes around the design, development and maintenance of its PARKIWATCH digital health solution. The message also suggests that regulatory approval and broader patient deployment represent the next steps in its roadmap.
For investors, ISO 13485 certification may be seen as a key prerequisite for entering regulated medical device markets and could help de-risk future regulatory submissions. It may also enhance Koios Care’s credibility with clinicians, partners and potential acquirers in the MedTech and digital health space.
The focus on Parkinson’s disease management positions the company within a specialized neurology segment where unmet clinical needs are significant. If Koios Care can successfully convert this quality milestone into regulatory clearances and commercial traction, the progress could support long-term value creation and differentiate its AI-based SaMD offering from less mature competitors.