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Recent technological advancements have resulted in a surge in the development and implementation of innovative medical devices to manage a broad spectrum of diseases. However, manufacturing these devices is fraught with challenges that can have detrimental implications for patient health1. Consequently, regulatory compliance is critically important for ensuring the safety and quality of devices that will directly impact patients2.
Nostos Genomics does not take this lightly, and our commitment to excellence has enabled us to achieve ISO 13485:2016 (ISO 13485) certification from the prestigious Notified Body, BSI3,4. This certification encompasses the ‘Design, Development, and Manufacturing of Clinical Decision-Support In Vitro Diagnostics (IVD) Software for Genetic Diseases’, marking a significant milestone in our commitment to quality and journey to compliance with the new In Vitro Diagnostics Regulation (IVDR)5. It applies to the manufacturing of AION, our AI-based software for clinical genetics tertiary analysis, and any other IVD software products that may be developed to support clinical decision-making in the diagnosis of rare genetic diseases. Here, we will discuss the importance of ISO 13485 for IVD medical device manufacturers and highlight what Nostos’ new ISO certification means for AION users and their patients.
Understanding ISO 13485 and IVDR
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Medical devices encompass any product intended to be used in the diagnosis, prevention, or treatment of a disease or medical condition that does not achieve its principal intended action by pharmacological, immunological, or metabolic means but which may be assisted in its function by such means6. This includes IVD medical devices: tools designed for in vitro examination of human body samples with the aim of providing information about physiological or pathological conditions, congenital anomalies, recipient compatibility, or monitoring treatments. AION is an IVD medical device that enables AI-driven variant interpretation to facilitate rare disease diagnosis.
Due to the risks associated with using medical devices in human subjects, the importance of safety and quality cannot be overstated and is demonstrated through the stringent regulatory requirements imposed on the medical devices industry, making it one of the world’s most highly regulated sectors4. In line with this, medical device manufacturers must demonstrate their commitment to quality through quality management systems (QMS). A QMS enables organisations to develop a framework of policies and processes that ensure a device meets regulatory and user requirements, guaranteeing its safety and clinical performance7,8. ISO 13485 is an internationally recognised standard that outlines the requirements for a QMS defining procedures for the design and manufacture of a medical device; it is intended to be used throughout the design, development, manufacturing, and post-market surveillance of a medical device4.
The IVDR is a comprehensive set of regulations introduced by the European Union (EU) to enhance the quality and safety of IVD devices5. Obtaining ISO 13485 certification from a Notified Body is a practical way for IVD manufacturers to achieve compliance with the new IVDR quality management system requirements by demonstrating their commitment to quality manufacturing through the implementation of a set of processes to guarantee safe and high-quality products.
In acknowledgement of the complexities faced by medical device manufacturers in achieving compliance, the implementation of IVDR has seen phased deadlines for existing devices with a current proposal for an extension of the transition period until December 2027 for Class D devices, December 2028 for Class C, and December 2029 for Class B and Class A sterile devices9. However, at Nostos Genomics, we firmly believe that ensuring medical devices meet the highest quality standards should be an urgent and essential priority for all medical device organisations, regardless of regulatory deadlines. Consequently, it remains critical that IVD manufacturers implement IVDR as soon as possible to enable users to ascertain the safety and high-quality care of patients.
The Impact of ISO13485 on AION Users and Their Patients
In recognition of our commitment to quality, Nostos Genomics is proud to have obtained ISO 13485 certification from the BSI, the most recognised Notified Body in the EU. This landmark achievement supports our regulatory strategic conformity route to achieve AION IVDR compliance in 2024. But what does it mean for our user and patient stakeholders?
First and foremost, ISO certification highlights the robust risk management, quality assurance, testing, and validation strategies we have in place, allowing us to equip our stakeholders with confidence surrounding software performance and diagnostic accuracy. ISO 13485 certification also ensures that all information pertaining to medical device manufacturing is meticulously recorded for full traceability and transparency and provides a framework for implementing and comprehensively recording post-market surveillance processes such as complaints, non-compliance, and corrective actions. Finally, by adhering to ISO 13485 requirements, we can guarantee that our expert team has the skills, knowledge, and competency to design, develop, and maintain the highest quality IVD software for genetic disease diagnostics.
Overall, ISO 13485 represents a customer-centric standard that focuses on user satisfaction and patient safety by ensuring manufacturers like Nostos Genomics adhere to stringent quality management practices throughout the IVD software lifecycle. By aligning with ISO 13485-certified manufacturing, AION users and their patients can trust the reliability, accuracy, and effectiveness of the disease-relevant variant interpretation supported by AION, enabling users to rely on our software for critical healthcare decision-making. The certification instills confidence by enforcing rigorous design, development, manufacturing, and post-market surveillance processes, ultimately translating into products that meet or exceed regulatory requirements and customer expectations.
Conclusions and Future Directions
In conclusion, ISO 13485:2016 certification marks a significant milestone in Nostos Genomics’ journey, aligning with IVDR and highlighting the quality and safety of our AI-based variant interpretation software, AION. Despite the extension of IVDR implementation deadlines, it is essential for IVD manufacturers to act now to improve QMS in line with global standards, not only to ensure compliance but also to guarantee excellence in patient care. For Nostos Genomics, certification marks a considerable achievement that signifies our commitment to patient safety and sets a foundation for future advancements in genetic disease diagnostics. Moreover, it supports our regulatory conformity route to achieve AION IVDR compliance in 2024, positioning us as frontrunners to become one of the first fully IVDR-certified providers in the industry.
To learn more about how our variant interpretation platform, AION, can support your mission to better patient care, schedule a free demo with one of our genomics experts today.
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References:
1. Kramer DB, Tan YT, Sato C, Kesselheim AS. Ensuring medical device effectiveness and safety: a cross-national comparison of approaches to regulation. Food Drug Law J. 2014;69(1):1-23, i.
2. Bianchini E, Mayer CC. Medical Device Regulation: Should We Care About It? Artery Res. Published online March 31, 2022. doi:10.1007/s44200-022-00014-0
3. What is the role of the Notified Body? Accessed March 12, 2024. https://www.bsigroup.com/en-IL/medical-devices/our-services/what-is-the-role-of-the-notified-body/
4. ISO - ISO 13485 — Medical devices. ISO. Published December 18, 2019. Accessed March 12, 2024. https://www.iso.org/iso-13485-medical-devices.html
5. Regulation - 2017/746 - EN - Medical Device Regulation - EUR-Lex. Accessed March 12, 2024. https://eur-lex.europa.eu/eli/reg/2017/746/oj
6. Medical devices. Accessed March 12, 2024. https://www.who.int/health-topics/medical-devices
7. Li TW, Tu PW, Liu LL, Wu SI. Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan. BioMed Res Int. 2015;2015:670420. doi:10.1155/2015/670420
8. Kheir O, Smedts S, Jacoby A, Verwulgen S. Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485). Med Devices Auckl NZ. 2021;14:313-319. doi:10.2147/MDER.S320583
9. Revision of the In Vitro Diagnostic Devices Regulation. European Commission - European Commission. Accessed March 19, 2024. https://ec.europa.eu/commission/presscorner/detail/en/IP_24_346
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