ISO 13485 Certification Granted to Presto Engineering

Presto Engineering has achieved ISO 13485 certification for its Denmark hub. The certification ensures the company’s 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,” Presto Engineering CEO Cedric Mayor said. “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.”
 
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. It requires meticulous quality management, technical documentation, method and planning. We are proud of this significant accomplishment of our Danish team,” Mayor added.
 
Presto Engineering is an independent ASIC design and semiconductor device production provider. From initial design to tape-out and the delivery of finished goods, Presto helps original equipment manufacturers integrate innovations and minimize overhead, while reducing risk and accelerating time-to-market. Presto offers more than 35-years of expertise in circuit design and industrialization for ultra-low power RF, high-touch analog mixed signal, and secured applications, including proprietary silicon IP platforms tailored to customers’ key product differentiation and competitive advantage. Presto is headquartered in Meyreuil, France, with operations and a dedicated supply chain across Europe, North America, and Asia.