4D Biomaterials Ltd, the manufacturing arm of UK-based university spin-out 4D Medicine Ltd, has today confirmed its attainment of ISO 13485:2016 certification, awarded by The British Standards Institution (BSI).
This internationally recognised benchmark for quality in medical device manufacturing signifies a major step forward in the company’s journey to market, underlining its commitment to safe, reliable, and customer-centred production standards.
The accreditation verifies that 4D Biomaterials Ltd operates within a robust quality management system compliant with global regulatory standards — a vital requirement for any raw materials intended for use in approved medical devices. With this in place, the company considerably strengthens its commercial positioning and reduces the regulatory risk profile of its offering.
Phil Smith, CEO of 4D Medicine Ltd, remarked:
“This achievement is a pivotal moment for our materials manufacturing business. ISO 13485 certification validates its operational systems and sends a clear signal to partners and investors: we are ready to scale. It also reflects the maturity of our technology platform, the discipline of our team, and our commitment to executing a high-quality commercialisation strategy.”
With certification secured, 4D is now strategically placed to fast-track commercial collaborations, regulatory clearances, and revenue-generating activity as it continues progressing its distinctive product portfolio towards global deployment.
