identify.bio, a computational pathology company, today announced that it has been certified to the prestigious EN ISO 13485:2016 standard.
Mumbai, India – 22 AUG 2023
ISO 13485 is a globally renowned standard that specifies
requirements for a quality management system for medical
devices including that of Software of a Medical Device (SaMD).
ISO 13485 is designed to be used by organizations, such as identify.bio, involved in the design and production of medical devices and related services.. The ISO 13485 standard was developed by the International Organization for Standardization (ISO) and is primarily based on the general standard for quality management known as ISO 9001. However, unlike ISO 9001, ISO 13485 was specifically designed for the medical industry and requires a defined approach to risk assessment and the management of each process necessary for the development and realization of regulated medical products. Companies that comply with these quality requirements must prove that they consistently review and validate their product development and manufacturing processes, manage their operations with effective procedures, and maintain records for product traceability.
The certification demonstrates that identify.bio has gone above and beyond in meeting international standards for quality management and patient safety.
“We hold ourselves to the highest standards and are proud to be ISO 13485 certified after just a over a year of incorporating our company,” said Rushabh A. Mehta, Co-Founder & CEO of identify.bio. “This certification is a testament to our commitment to quality and patient safety. It also demonstrates our ability to meet the rigorous requirements of the medical device industry.”
identify.bio prides itself in its innovation and desire to bring new technologies and algorithms into the market. However, this would mean little without ensuring that the company has the correct systems in place to ensure safety and reliability.
ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device
quality requirements in the international market. ISO 13485 is aligned with European medical device directives; therefore, its implementation helps to fulfil the requirements of these directives to obtain CE certification. FDA's Quality System Regulation Part 820, is harmonized with ISO 13485
The ISO 13485 certification is not an evaluation of a product, but rather the Quality Management System and safety protocols put in place by the company. In this regard, a third party entity performs an on-site audit to ensure adherence to the standard. Some areas that an auditor examines include - Standard Operating Procedures to govern every aspect of the business, product development lifecycle, customer satisfaction and addressing complaints and shortfalls; Cybersecurity and the protection of sensitive customer and patient data; Rigorous and ongoing testing of the platform.
The ISO 13485 certification is a significant milestone for identify.bio. It is a recognition of the company’s commitment to quality and patient safety. The certification will also help Identify.bio to expand its market reach and to attract new customers.
About identify.bio –
Headquartered in Mumbai, India identify.bio has developed its first AI algorithm – The Pap Smear Pre Screening Tool, used to pre-screen Liquid Based Cytology Pap smear specimens before diagnosis by the pathologist / cytotechnician as the case may be. The algorithm will flag cases suspicious for abnormalities for further review by the pathologist / cytotechnician. The rest of the slides require no further review.