ASIC-specialists danske enhed får vigtig medico-godkendelse

Presto Engineering er blandt de førende europæiske leverandører af ASICs. Firmaets danske enhed har netop fået en ISO 13485 certificering, der specificerer krav for kvalitetsmanagement-systemer for leverandører af medicoprodukter (in english).

Presto Engineering, a leading European expert in application-specific integrated circuit (ASIC) design, engineering and production services, is pleased to announce that it 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 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, says 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.

Cedric Mayor adds:

- 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.

About Presto Engineering

Presto Engineering is a leading 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 uniquely offers over 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.