Fast MDx Ltd. achieves ISO 13485:2016 Quality System Certification

October 25, 2023 - London, UK: Fast MDx Ltd, a UK-based molecular diagnostics company who are focussed on the development of medical diagnostics for faster and more accurate diagnosis in healthcare, has announced completion of the ISO 13485:2016 certification.


ISO 13485 is a globally recognised standard, published by the International Standards Organization (ISO), setting out the requirements for quality management systems for diagnostics and medical devices. The ISO quality standard is awarded to manufacturers who demonstrate excellence in quality management and best practice for design, manufacture or supply and hence meeting the regulatory requirements specific to the IVD industry.


Fast MDx Ltd. is a molecular diagnostics company focussed on development of medical diagnostics for faster and more accurate diagnosis in healthcare, announced it has completed the quality management ISO 13485:2016 certification audit for the design and development and manufacture of molecular diagnostic platforms for infectious diseases.  


The completion of the ISO 13485:2016 certification audit exemplifies Fast MDx’s commitment to meeting the highest standards of quality, reliability and safety in the medical device industry.


“ We are very proud to receive the ISO 13485:2016 certification; this achievement demonstrates our continuous commitment to consistently high standards in our quest to deliver the Fast MDx platform.” said Richard Lewis, CEO.


“Fast MDx are focussed on delivering the world’s first, low-cost, high-throughput, near-patient molecular diagnostic test system, and our ISO accreditation is another successful step in the journey.”


About Fast MDx Ltd.


Fast MDx Ltd. is a social enterprise company which provides molecular diagnostic testing that has the potential to benefit society whilst having less impact on the environment. With almost half of the world’s population having little or no access to diagnostics1, the goal is to provide affordable molecular diagnostics in more countries and in more settings.


For more information


Visit the company website at www.fastMDx.com or contact  info@FastMDx.com



  1. Fleming KA et al.  The Lancet Commission on diagnostics: transforming access to diagnostics. Lancet. 2021 Nov 27;398(10315):1997-2050. doi: 10.1016/S0140-6736(21)00673-5. Epub 2021


##   END  ##


Cytox awarded new Innovate UK funding for Alzheimer’s disease testing

8 March 2018: Oxford & Manchester, UK. Cytox, an emerging precision medicine leader providing geneti...

Read More >

Press Release - RQM+ Launches Reimbursement Division

RQM+, the leading MedTech service provider with the world’s largest global team of regulatory and q...

Read More >

OGT pushes forward hybridisation-based targeted sequencing

Oxford, UK – 25 May 2017. Oxford Gene Technology (OGT), The Molecular Genetics Company, has made se...

Read More >

Helping You Stay Comfortable and COVID Secure

New Range of CE Certified Face Visors and Type II Masks with Introductory 10% Savings

Read More >

RPS Diagnostics partners with Atomo Diagnostics to develop next generation Febridx blood tests for Antibiotic Stewardship in the Outpatient setting

Sarasota, Florida and Sydney, Australia (February 20, 2018) – United States biotechnology company, ...

Read More >

Diagnostics for the Real World (DRW) achieves UK technical validation for two multiplex respiratory virus rapid tests

New combined tests deliver highly accurate point-of-care detection for SARS-CoV-2, Flu A, Flu B and ...

Read More >