Product Development
We develop complex medical systems
As development experts, we support our customers with hardware and software development, ranging from individual components to complete product development.
Within the scope of product development, you will benefit from our interdisciplinary team at every stage of development – our experts in mechanics, electronics and software will support you with their in-depth understanding of technology. In close cooperation, we implement your component or transform your idea into a medical product ready for series production. Of course, we always take into account all applicable regulations and standards, including the requirements of the Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA).
MECHANICS, ELECTRONICS, EMBEDDED SOFTWARE
Our service packages in product development
Mechanics and design
Precision meets innovation
Our design engineers and mechatronics technicians design assemblies according to your specific requirements. Using rapid prototyping techniques, we can quickly and accurately create prototypes to validate design ideas and develop optimized solutions for medical devices. This allows us to efficiently respond to customer feedback and realize high-quality mechanical components that combine functionality, aesthetics and usability.
Application examples
Equipment technology
Drive trains
Housing design
Industrial design
Actuators and motors
Injection molding
Sensor integration
Conveyor technology
Rapid prototyping
Additive manufacturing
Electronics
State-of-the-art technology for sophisticated devices
On behalf of our customers, we develop electrical and electronic circuits that are precisely tailored to their specific needs. In this way, we ensure the highest performance, reliability and safety of the medical devices we develop. Our extensive experience ranges from the seamless integration of small sensors to the development of complex, multilayer circuit boards.
Application examples
Circuit design
Circuit simulation
PCB layout
Control engineering
Electromagnetic Compatibility (EMC)
Prototype circuit boards
Measurement techniques
Microcontroller
TI, STM, Microchip, Atmel, Altera, Freescale, NXP, etc.
Control elements
Keys, display, touch screen, etc.
Embedded software
Intelligent solutions seamlessly integrated
Application-specific embedded software is an integral part of active medical devices. Our embedded software development is closely intertwined with our other development areas to achieve smooth integration of the software with the hardware. This enables us to develop reliable, error-free and efficient software solutions that are optimally adapted to the specific requirements of the medical devices; of course in compliance with the requirements of IEC 62304.
Application examples
Microcontroller-based device control systems
Multi-processor systems
Integrated Real-time Operating Systems (RTOS)
Complex embedded systems
Graphical User Interfaces (GUI)
FROM THE IDEA TO THE FINISHED DEVICE
We take over the development in every phase
Phase 1: Idea
Phase 1: Idea
Feasibility & Prototyping
You want to have a product idea checked for feasibility and you want have the exact technical requirements evaluated? We carry out feasibility studies for you and draw up a development plan in accordance with ISO 13485.
Phase 2: Specification
Phase 2: Specification
Requirements & System Engineering
Requirements & System Engineering
We identify, specify and review the requirements of all stakeholders for you. This is the only way to develop a medical product that meets the needs and wishes of all stakeholders.
We identify, specify and review the requirements of all stakeholders for you. This is the only way to develop a medical product that meets the needs and wishes of all stakeholders.
Phase 3: Safety
Phase 3: Safety
Risk Management
During development, we analyze risks according to ISO 14971 and define measures for risk mitigation. We are also happy to support you in the risk management of your in-house development.
Phase 4: Usability
Phase 4: Usability
Usability Engineering
From the very beginning, we develop with the usability of your product in mind. To this end, we conduct formative and summative usability studies in accordance with EN 62366.
Phase 5: Performance
Phase 5: Performance
Verification and Validation
During verification, we prove that the product developed for you complies with all specified product requirements and the relevant standards (especially the EN 60601 family). We validate your product to prove that it meets all the user requirements.
Phase 6: Series Production
Phase 6: Series Production
Design Transfer
We are happy to establish production processes and procedures for you. This can be carried out in your production facilities or at a contract manufacturer.
You might also be interested in
Expertise
Our expertise ranges from active medical devices to non-magnetic products and the Internet of Medical Things (IoMT).
Read more →
Company
What is our philosophy? Who are your contacts? And how do we ensure a consistently high level of service?
Read more →