GenomeArc Horizon Earns ISO 13485:2016 Certification for Excellence in Medical Device Quality Management
Mississauga, ON, Canada, GenomeArc is proud to announce that the GenomeArc Horizon Platform has officially achieved ISO 13485:2016 certification, the globally recognized standard for quality management systems in medical devices and diagnostics. This certification underscores GenomeArc’s unwavering commitment to delivering the highest standards of safety, reliability, and performance in genomic data analysis and interpretation.
ISO 13485 certification, mandated by Health Canada for medical-grade software solutions, marks a major milestone for GenomeArc. It validates that Horizon meets the rigorous regulatory and quality requirements necessary for clinical and diagnostic use. This achievement now enables GenomeArc Horizon to enter the Canadian healthcare market while also paving the way for regulatory recognition in international markets. GenomeArc is advancing Rare Disease, Oncology and Pharmacogenomics Solutions with Relentless Commitment to Quality.
With this certification, GenomeArc reaffirms its mission to transform clinical genomics through precision, transparency, and trust. The Horizon platform powered by AI-driven analytics and multi-omics integration continues to advance rare disease and oncology diagnostics globally, empowering clinicians and researchers with cutting-edge insights for better patient outcomes.
GenomeArc Inc. is a biotech company on clinical genetics and drug discovery headquartered in Mississauga, Ontario. The company began its journey in 2021, GenomeArc develops artificial intelligence integrated solutions for genetic diagnosis and genomic drug development solutions for rare genetic disorders and pan cancer. As a research-oriented biotech company, GenomeArc brings new insights into rare diseases, cancer diagnosis, and therapeutics through genome analysis. The GenomeArc team is constantly innovating technologies to solve phenotypic complexities in genetic variations for rapid intervention. As a global company, our aim is to make efficient and accurate genome medicine technologies accessible for all healthcare systems.
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