ASIC specialist, Presto Engineering, has successfully passed EN ISO 13485 certification, the internationally recognized quality benchmark for medical device manufacturers. The certification covers Presto’s Denmark hub to ensure its ASIC design and production services consistently meet medical device customer expectations and relevant regulatory requirements.
Presto Engineering’s CEO, Cedric Mayor, said: “The EN ISO 13485 quality management certification is a significant accomplishment for our Denmark hub, which boasts 35 years of experience in ASIC design for medical devices. This certification is the paramount
of a long journey for our MedTech ASIC roadmap and recognizes Presto’s breadth of experience in designing ASICs for applications such as in vitro diagnostics, patient monitoring, medical wearable devices, imaging and more. It anchors our capability to provide high-quality, safe solutions for our customers in the medical field.”
EN ISO 13485 includes requirements for design and development, risk management, production and post- production processes for medical device manufacturers and their suppliers.