Cover story
Hamilton Medical, for example, uses COM-Express modules such as the 15CC10C from duagon in several of its ventilator product lines
Standards-compliant hardware development and product maintenance There are further overlaps between the railway and medical technology sectors in terms of the high level of regulatory requirements and certifi cation procedures for safety-critical applications. “That’s part of our daily routine,” says Dr Jungmann. To date, duagon has primarily supplied large medical device manufacturers, “who audit us and integrate us into their processes.” To make itself attractive as a development partner and supplier to small and medium-sized OEMs and device manufacturers as well, duagon is aiming to obtain ISO 13485 certifi cation for its quality management system this year. “We know how complex it is for OEMs and device manufacturers to outsource development services to partners like us.” duagon already provides documentation for approval by notifi ed bodies alongside its embedded hardware – namely, design and development documentation, declarations of conformity, risk management documentation in accordance with ISO 14971, or any software documentation in accordance with IEC 62304. This also includes the results of various test reports, such as electrical and electronic safety tests in accordance with IEC 60601 or EMC tests. “With the ISO 13485 certifi cate, we aim to build further trust among our customers in our 20 years of expertise in medical technology and in all these standard processes.” This also includes the routine management of product
lifecycles that are longer than average. “Established and certifi ed systems often remain in operation for several decades in both medical technology and railway technology,” confi rms Dr Jungmann. Changes or new developments are complex, cost- intensive, and usually require new approvals. However, because laws and regulations change simultaneously (e.g., regarding cybersecurity), technologies continue to evolve, and suppliers of individual components (e.g., CPUs, RAM, memory, etc.) switch to new product lines, changes must occasionally be made to existing hardware designs. “We have a corresponding lifecycle management system in place that allows us to offer above- average delivery times and, if necessary, notify customers of required changes well in advance.”
The G029 is a high-performance single-board computer compliant with IEC 60601. It is part of a modular CompactPCI Serial system that allows customers to assemble the right hardware platform from a variety of boards
Hardware solutions from duagon for medical and laboratory equipment include:
• Embedded System Modules (ESM) • COM Express Modules (COMe) • Modular, high-performance computing hardware (e.g., based on CompactPCI Serial) • FPGA programming • System-on-Chip • Microcontrollers
• Board Support Packages
• Compliance with standards (including IEC 60601) • Extremely rugged hardware for demanding environmental conditions: Vibration, shock, dust, humidity, extreme temperatures • Support services for exceptionally long lifecycles
Contact the duagon Medical Team at:
www.medtech.duagon.com
www.electronicsworld.co.uk April 2026 07
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