Congenica, Cambridge, UK, has received certification to ISO 13485:2016, the quality systems standard for medical device manufacturing compiled by the International Organization for Standardization (ISO), which supports comprehensive policies and processes across the entire business.
ISO 13485 is a global standard for medical devices and in vitro diagnostic production. In achieving certification to the standard, Congenica has demonstrated that it 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 Asia, Europe, and the United States.
“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,” says David Atkins, PhD, chief executive of Congenica. “This will help us achieve our goal to accelerate accurate genomics-based clinical support, which will ultimately benefit patients and their caregivers worldwide.”
“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,” says Heather Carré-Skinner, PhD, quality assurance and regulatory affairs manager at Congenica. “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 4-day final audit that involved a thorough review of policies and processes for Congenica’s business, including customer support, design and development, human resources, and sales.
Congenica’s Sapientia clinical genomics platform is currently being used in Genomics England’s 100,000 Genomes Project, and also supports China’s national 100K Wellness Project and Portugal’s In2Genome Project.
“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,” Atkins says.
For more information, visit Congenica.