We are proud to announce Hi-Technology Group has achieved ISO 13485 certification for both our Kosice, Slovakian and our Waterlooville, UK plants for the manufacture and assembly of medical devices, marking a significant milestone in our commitment to quality, compliance, and customer confidence.
ISO 13485 is the internationally recognised gold standard for medical device quality management systems. Certification demonstrates that across the Hi-Tech Group our processes meet stringent regulatory requirements, ensuring consistent product safety, traceability, and reliability.
Our certification covers both component manufacture and full product assembly, including precision tooling, controlled assembly operations, inspection, testing, and validation. This means customers can rely on a single, fully compliant source for high-quality medical device production.
Achieving ISO 13485 reflects our investment in systems, infrastructure, and team expertise. It strengthens our ability to support current and future medical device programmes while ensuring adherence to the highest quality standards. We remain committed to continuous improvement, operational excellence, and providing solutions that meet the evolving needs of the medical device industry.
