Abomics has renewed its ISO 13485:2016 certification, confirming that its pharmacogenetic reporting and clinical decision support solutions meet internationally recognized quality standards. The certification reinforces consistent, risk-based processes that support safe and reliable implementation.
Abomics is proud to announce the successful renewal of its ISO 13485:2016 certification, following an external audit conducted by SGS Fimko. This renewal demonstrates our continued commitment to the highest standards of quality, safety, and regulatory compliance in the development of medical software and pharmacogenetic reporting solutions. Abomics has maintained ISO 13485:2016 certification since 2023, underscoring the continuity of our quality-driven approach.
ISO 13485:2016 is the globally recognized quality management system standard for medical devices and related services. The renewed certification confirms that Abomics’ processes, documentation practices, and quality workflows consistently meet international expectations for safety, reliability, and operational excellence.
At Abomics, our work is driven by dedicated focus on quality. Our renewed certification covers the development and maintenance of our pharmacogenetic interpretation services, database solutions, and clinical decision‑support tools used by healthcare professionals across Europe and beyond.
This achievement reflects our dedication to:
The renewal of the ISO 13485:2016 certification reinforces Abomics’ role as a trusted partner for healthcare providers, laboratories, and integrators working to improve medication safety through personalized medicine. As regulatory expectations evolve globally, we remain committed to staying ahead, ensuring our solutions maintain the highest quality standards now and in the future.
Abomics is now part of the Fingenious Ecosystem, bringing the company closer to Finland’s biobank network and research-grade genetic data. This collaboration opens opportunities to use this data to support more personalized medication decisions.
Mikko Välimäki has been appointed to Abomics’ Board of Directors, while Ari Hakkarainen has concluded his term. Välimäki brings extensive experience in technology companies, entrepreneurship, and international growth, strengthening the Board’s work in supporting the company’s long-term development.
Abomics has appointed a new Lead Bioinformatician to deepen its expertise in genomics and pharmacogenetics. The role strengthens scientific capabilities behind clinically actionable solutions and supports the practical implementation of precision medicine in healthcare settings.