NOTTINGHAM, UK. 3rd April, 2025 – 4D Biomaterials Ltd, the materials manufacturing subsidiary of 4D Medicine Ltd, a UK university spin-out company developing next-generation bioresorbable medical devices, today announced it has achieved ISO 13485:2016 certification from The British Standards Institution (BSI).
This globally recognised quality standard for medical device manufacturing marks a critical milestone in the company’s path to market, demonstrating high quality, low risk and customer-focused manufacturing capability.
This globally recognised quality standard for medical device manufacturing marks a critical milestone in the company’s path to market, demonstrating high quality, low risk and customer-focused manufacturing capability.
The certification confirms that 4D Biomaterials Ltd operates under a quality management system that meets stringent international regulatory requirements — a core prerequisite for the raw materials used in medical devices seeking regulatory approvals, clinical deployment, and global distribution. As such, certification significantly de-risks the company’s commercial strategy.
Phil Smith, CEO of parent company, 4D Medicine Ltd commented:
“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 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 milestone positions 4D to accelerate the development of commercial partnerships, regulatory approvals, and revenue-generating opportunities as it advances its differentiated product pipeline toward global markets.
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