Genomics is advancing rapidly, and whole genome sequencing (WGS) has emerged as a powerful tool for discovering the mysteries of the human genome. WGS offers unprecedented insights into genetic variations, disease predispositions, and personalized medicine due to its ability to decode the entire DNA sequence. As the demand for accurate and reliable genetic analysis grows, it is increasingly important for a comprehensive genetic analysis solution to meet certification standards such as ISO 13485. Geneyx is well on our way to getting the CE Mark certification.
What is ISO 13485 Certification?
ISO 13485 is designed for medical equipment and software manufacturers to ensure an internationally recognized standard for quality management. It ensures that companies meet a set of stringent quality measures regarding safety, effectiveness, and compliance with regulatory bodies. Geneyx’s commitment to maintaining the highest quality standards and compliance with regulatory requirements is demonstrated through this ISO 13485 certification.
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Here Is How We Ensure Quality and Regulatory Compliance in Our Whole Genome Sequencing Solution
The ISO 13485 certification plays a critical role. Quality management is ensured and incorporated into all development and management procedures every step of the way. This is not a once-off achievement with a gold stamp of approval. Geneyx is committed to ensuring accuracy, reliability, and reproducibility when making clinical decisions.
The Significance of ISO 13485 Certification for Genetic Analysis Platforms
The ISO 13485 certification signifies a commitment to excellence for our whole genome sequencing analysis solution. Not only this, but also it is an important step in getting the CE Mark certification, which we are well on our way to getting now.
We ensure that our solution has implemented stringent quality control measures, rigorous documentation practices, and comprehensive risk management strategies. We will continue to boost the credibility and reputation of the Geneyx Solution and inspire trust and confidence in our customers, including all the hospitals, laboratories, research centers, and universities we work with and rely on our solution for their cohort clinical genetic analysis.
A Perfect Match: Whole Genome Sequencing and ISO 13485
ISO 13485 certification aligns perfectly with the requirements of a whole genome sequencing platform, ensuring that quality management is exercised at every step of the analysis process using standardized quality procedures.
Geneyx was founded with the vision that every patient deserves to be diagnosed and treated with the value of genomics knowledge through a clinical genetics data management platform analyzing and interpreting NGS data with the most recent technological advances. Implemented in more than 35 countries with over 210,000 data uploads, users of private/public laboratories, hospitals & National Genome Projects have produced diagnostic yields of up to 65% with batch uploads of WEexome sequencing analyzed in less than 30 minutes and WG in 2.5 hours.