DoMore Diagnostics has successfully completed ISO 13485 certification
Oslo, Norway - DoMore Diagnostics, a leader in deep learning precision diagnostics in digital pathology, today announced that the quality management system (QMS) has been certified as compliant with the ISO 13485 standard. The certification audit process was conducted by DNV (notified body).
“Since the company’s inception, quality has been a top priority. We started immediately to build a robust quality management system and are committed to live up to the highest quality and regulatory standards. In May we obtained the CE-mark, and the ISO standard QMS ensures that our products are safe and reliable. Going forward we will facilitate seamless delivery to customers on their existing digital pathology systems. This has been a true team effort lead by Elisabeth, who continues to impress with her mastery of the QA arena”, said Torbjørn Furuseth, CEO and Co-founder in DoMore Diagnostics.
About ISO13485
ISO 13485 is a globally recognized international standard for Medical Devices and In-vitro Diagnostics, describing requirements for quality management system for regulatory purposes and contains a comprehensive quality management system for design and manufacture of medical devices. ISO 13485 specifies requirements where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements for design and manufacture of medical devices.
“I am very impressed with the team. The recipe for success is everyone acknowledging the importance and participating to create a QMS that is applicable to our work processes. We maneuver in a complex regulatory landscape and creating products with potentially high importance on patient treatment decisions. We are very grateful to DNV for conducting the certification audit process in a thorough and collaborative manner and look forward to work closely with them in the years to come. I am very happy with the result and excited to continue to develop high quality diagnostic tools for clinicians and patients world-wide”, said Elisabeth M.J. Klaussen, Head of QA and Regulatory in DoMore Diagnostics
About DNV
DNV is one of the world’s leading certification bodies, helping businesses assure the performance of their organizations, products, people, facilities and supply chains. With the HQ in Norway, they have offices in across the globe and operations in more than 100 countries, working with some of the world’s leading companies.