Congenica Achieves Global ISO 13485:2016 in vitro Diagnostic Device Quality Management Systems Certification
Cambridge, UK – 28 February 2018 – Congenica, a global provider of clinical genomics interpretation software announced today that it has received certification in ISO 13485:2016, a quality management system for medical devices that supports comprehensive policies and processes across the entire business.
ISO 13485 is a global standard for medical devices and in vitro diagnostic (IVD) production. In achieving this standard, Congenica has demonstrated that it meets the increasing needs of international healthcare providers, clinicians and patients. It also provides the standardized and stringently regulated quality-controlled products required by the emerging field of precision medicine, and supports the Company’s ongoing expansion in Europe, the US and Asia.
Congenica’s recently appointed CEO Dr David Atkins said: “As we expand our international commercial operations and continue product development of our gold-standard Sapientia™ clinical genomics software platform, conforming to the ISO 13485 standard is a key step in preparing to access global markets. This will help us achieve our goal to accelerate accurate genomics-based clinical support, which will ultimately benefit patients and their care-givers worldwide.”
Congenica’s Quality Assurance and Regulatory Affairs Manager, Dr Heather Carré-Skinner said: “Certification to ISO 13485:2016 shows Congenica’s commitment to customer needs and patient safety, as well as allowing systems to be in place that will help us successfully navigate the increasing demands from clinical best practice and regulations. As Congenica is already certified to ISO 27001:2013, we are in a leading position that combines high standards in design and development with rigorous data and information security practices.
ISO 13485 registration required a four day final audit that involved a thorough review of policies and processes around Congenica’s business, including design and development, Customer Support, Sales and HR. Congenica’s Sapientia clinical genomics platform is currently being used in Genomics England’s ground-breaking 100K Genomes Project, and also supports China’s national 100K Wellness project and Portugal’s In2Genome Project.
Dr Atkins continued: “The ISO 13485 certification for Congenica further strengthens our credibility with existing and potential customers, and we look forward to expanding our international collaborations and partnerships in 2018.”