4D Biomaterials Ltd Awarded ISO 13485 Certification, Strengthening Route to Market

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UK-based 4D Biomaterials Ltd, the materials production subsidiary of 4D Medicine Ltd — a university spin-out focused on pioneering bioresorbable medical technologies — has officially received ISO 13485:2016 certification from The British Standards Institution (BSI).

As a globally endorsed quality benchmark for medical device production, this certification signifies a vital advancement in the company’s commercial trajectory, highlighting its capability for high-quality, low-risk, and customer-focused manufacturing.

This milestone confirms that 4D Biomaterials Ltd upholds a quality management system that aligns with stringent international regulatory standards — a critical foundation for supplying raw materials into regulated medical devices. Achieving certification significantly mitigates commercial risks, bolstering confidence in the company’s strategy.

Phil Smith, CEO of the parent company 4D Medicine Ltd, said:

“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.”

This accomplishment positions 4D to move swiftly in securing strategic partnerships, regulatory approvals, and new revenue streams as it advances its innovative product pipeline into international markets.