Presto Engineering Obtains ISO 13485 Quality Management Certificate for Medical Devices :: I-Connect007

Presto Engineering, a leading European expert in the design, engineering and manufacturing of application-specific integrated circuits (ASICs), is pleased to announce that it has successfully passed EN ISO 13485 certification, an internationally recognized quality benchmark for medical device manufacturers. The certification covers Presto’s Danish center to ensure that its ASIC design and manufacturing services consistently meet customer expectations for medical devices and relevant regulatory requirements.

“The EN ISO 13485 quality management certification is a significant achievement for our Danish center, which has 35 years of experience in ASIC design for medical devices,” said Cedric Mayor, CEO of Presto Engineering. “This certification is the most important achievement in a long journey for our MedTech ASIC plan and confirms Presto’s extensive experience in ASIC design for applications such as in vitro diagnostics, patient monitoring, wearable medical devices, imaging and others. It is the foundation of our ability to deliver high-quality, safe solutions to our customers in the medical industry.”

EN ISO 13485 covers 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 includes customer and regulatory requirements and promotes continuous improvement, safety and risk management. All activities related to the design, development and production of the Danish Presto hub are covered.

Mayor adds: “The path to strict compliance with international regulatory requirements for medical devices requires a multi-faceted approach, and EN ISO 13485 is a key element. It requires meticulous quality management, technical documentation, method and planning. We are proud of this significant achievement by our Danish team.”