We are proud to announce that our wholly-owned subsidiary, 4D Biomaterials Ltd, is now certified to ISO 13485 – the globally recognised standard for medical device quality management systems.
This marks a major step in our commercialisation strategy and it validates the growing maturity of our manufacturing operation as we move towards market entry.
CEO Phil Smith: “This certification by the British Standards Institution (BSI) validates our readiness to manufacture the 4Degra range of photo-polymer resins at scale to supply both our internal customer, 4D Medical Devices Ltd, and other strategic partners in the medical device sector. It also shoes that we’re building not just innovative products, but a high-quality, investable business. Big thanks to our Quality Manager, Karl Houghton, and the whole 4D operational team, who have worked so hard to achieve this goal.”
With this accreditation in place, we are well-positioned to accelerate regulatory submissions in preparation for clinical deployment, as we forge new partnerships to deliver world-class solutions in the fast-growing field of bioabsorbable medical devices.
