EN ISO 13485 is an international standard which specifies the requirements in terms of quality management system for medical-device manufacturers and their supply chains.
Presto Engineering, a European provider of application-specific integrated circuit (ASIC) design, engineering and production services, passed EN ISO 13485 certification, which is the internationally recognized quality benchmark for medical-device manufacturers. The certification covers Presto’s Denmark hub to ensure that its ASIC design and production services consistently meet medical-device customer expectations and relevant regulatory requirements.
“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,” said Cedric Mayor, CEO of Presto Engineering. “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. The certification requires a quality management system that encompasses customers and regulatory requirements and promotes continuous improvement, safety and risk management. All of the design, development and production activities of Presto's Danish hub are covered by its scope.
“The journey to strict compliance with international regulatory requirements for medical devices entails a multi-faceted approach, with EN ISO 13485 serving as a key component,” added Major. “It requires meticulous quality management, technical documentation, method and planning. We are proud of this significant accomplishment of our Danish team.”
From initial design to tape-out and the delivery of finished goods, Presto helps original equipment manufacturers (OEMs) to integrate technology. Presto is headquartered in Meyreuil, France, with operations and a dedicated supply chain across Europe, North America, and Asia.
