SMi receives ISO 13485 certification
Published on 26/06/2025
SMi Systems has received certification from the British Standards Institution (BSI), the UK’s National Standards Body.This certifies that SMi operates a Quality Management System (QMS) which complies with the requirements of ISO 13485:2016 for the design and development of IVD instruments to aid the detection of infectious and non-infectious diseases in patient samples.
ISO 13485 is a medical device standard that establishes best practice for management processes developed to produce safe and high-quality medical devices. Its primary focus is on patient safety by ensuring consistent quality throughout the entire lifecycle of medical devices, from design and production through to disposal. It helps to ensure that medical device regulatory requirements are met and that all medical devices conform to compliance laws and meet customer needs.
In building its QMS, SMi’s in-house team worked closely with medtech clinical consultants from ProPharma Group and all development team members undertook required training with Medical Device HQ. “From the outset we sought to build our development processes to meet the requirements of ISO 13485” said Stephen Reeder, COO at SMi. “Making quality management part of our foundation helps us to develop better products more effectively”.
“SMi took the view that the company would conform to the highest regulatory standards from day one of operations. This ensured the highest quality of products across our portfolio and provided a framework for all activities within our company” says Dr Andrew Thompson, CEO at SMi. “This recognition from a globally recognised institution is a major achievement that allows diagnostics developers to develop their own diagnostic tests for use on SMi’s platform
About SMi:
SMi is an innovative life science technology company with a fast and automated, high throughput single-molecule imaging platform. SMi’s benchtop platform offers multiplexing and assay flexibility that allows accurate and reliable detection of a broad range of molecule types within a single test. Established with a vision to bring its platform to every laboratory, SMi delivers world-class results without the need for specialised knowledge and infrastructure. By delivering single molecule data at volume and speed, it ensures that earlier and informed decisions can reliably drive the future of biomedical research and diagnostics.
For more information on SMi’s new platform and its single-molecule imaging technology, please visit https://smisystems.co.uk
