Engineering
Engineering Services
From the idea to market maturity – Our development
In partnership with national and international customers, seleon develops individual solutions for complex medical technology devices. Through extensive engineering knowledge and years of experience, we consistently and efficiently transform your ideas into medical technology products and lead them safely towards “time to market”.
In particular, the professionalism of our experts in the fields of systems engineering, design, electronics, software and firmware allows us to draw on a wide range of technologies. Our customers thus benefit from the specialized knowledge of our interdisciplinary development teams throughout the entire product development process – from conception to the development of functional samples, prototypes and final products. As medical technology experts, we observe all relevant regulations and applicable standards right from the start of the design phase.
An Overview of Our Engineering Services
Project Management
Project management controls the balance in the triangle of tension between financial budget, time budget and quality of the concept to be implemented.
As the interface between our customers and our development teams, project management assumes responsibility for the successful progress of the project.
All projects are supervised by our experienced and competent project managers, who provide maximum project transparency, have the customer’s needs firmly in mind and know that communication is an important success factor of every project.
Our project managers accompany all customer projects from the initial requirements, through the feasibility study, preparation of the specifications/requirements sheet, development of functional samples and prototypes, clinical studies, approval, tool development, work preparation, to pilot production.
- Project management in terms of budget, time and quality
- Continuous refinement and adaptation of the project plan
- Planning of required human resources at the right time to the development teams
- merging our human resources with those of our customers
- Escalation of problems
- organizing, leading and moderating workshops, regular project conferences on site or at the customer’s premises or as telephone and video conferences
Regular status reports on the project status
Ensuring that the development process conforms to standards in accordance with the quality management requirements in medical technology
System Development
System development is the physical-technical bracket in our development projects.
Together with our project managers, the respective system concept is developed according to your ideas. From the very beginning, special emphasis is placed on the safety of the medical product and on conformity with European and international standards. If required, the feasibility of your ideas or those developed with us can be proven by means of test setups or demonstrators within the framework of upstream studies. For this purpose, powerful software tools for test control and fast result visualization as well as software tools for simulation are available.
When developing customized metrological solutions, you benefit from our valuable industry experience and our in-depth knowledge of physics and metrology.
We are also happy to develop novel processes together with you, which we will supervise on your behalf until the patent is granted. System development accompanies your development project throughout the entire development cycle, through verification of the requirements from the specifications up to approval.
- Creation of system concepts for complex medical devices in close coordination with the customer and project management
- Selection of suitable system components as well as their systemic and cost optimization and coordination with the procurement department
- System modeling and simulation
- Planning, implementation and tracking of prototyping activities
- Support in the construction and further development of test setups and prototypes as well as in system integration
- Patent research, development of patentable solutions, patent preparation and support of patent procedures
- Laboratory proof of feasibility by means of test setups
- Development-accompanying tests, as well as development-final verification and their documentation
You have access to all specialist areas that are necessary for the development of complex medical technology systems. The specialized knowledge of our interdisciplinary development teams is available to you throughout the entire product development process – from conception and the development of functional models and prototypes to approval and series production.
By bundling all work steps of a project, our customers can benefit from decisive cost advantages, save time and ultimately hold the best possible result for market success in their hands.
Electronics
Within our electronics division, we offer almost all development services relevant to medical technology, such as the development of PCBs from two-level to multilayer PCBs, analog and digital measurement circuits, microcontroller systems, control technology, data acquisition and processing systems, and much more. We create both the circuit design and the PCB layout in-house and, of course, consider EMC-compliant development from the very beginning.
Our knowledge and applications are based on the complex wealth of experience of our specialists with microcontroller systems, such as Renesas, TI, STM and Atmel as well as DSP, analog and digital data acquisition and processing, the use of actuators, such as motors, blowers, valves, solenoids, sensors (for flow, pressure, temperature, humidity), displays (numeric, alphanumeric, graphic) as well as operating elements (keys, membrane keyboards). Our experts work, for example, with the interfaces Ethernet, USB, CAN, RS-232, RS-485, SPI, I2C, the memory options Flash, SRAM, EEPROM as well as with the radio interfaces WLAN, Bluetooth, RFID.
- Circuit diagram creation
- Layout (from two-level to multilayer PCBs)
- Circuit simulation
- Complete EMC-compliant design
- Incircuit tests
- Conformity (CE, UL, ROHS)
- Prototype PCBs
- Inspector software
Software/ Firmware
ai6 Solutions offers professional services in the development of software and firmware for medical devices. We develop customized solutions for all common hardware and software platforms.
In addition to conception, realization, testing and documentation, we also take over the commissioning as well as the subsequent support of the product, if desired. Approval processes are intensively prepared and accompanied by us together with you.
The spectrum ranges from simple microcontroller-based device control to more complex embedded systems to multi-processor systems for life-supporting or safety-relevant applications. We also realize appealing and specially optimized user interfaces as well as operating workflows and the adaptation and integration of real-time operating systems.
The connection of external PCs and servers as well as mobile devices completes our offer.
A seamless link between software and product development process is always guaranteed. Consideration of the interfaces to system engineering, hardware development, risk management and quality management and the integration of the associated activities contribute to the high quality of the software.
Our software development process implements the requirements of IEC 62304 and the FDA for the development of software for medical devices. The documentation associated with the medical device meets the applicable normative and regulatory requirements.
Mechanics / Mechantronics
Our core competencies include the interaction of mechanical, electronic and information technology modules in mechatronic systems.
We design plastic and metal components in ProEngineer and SolidWorks and also organize prototyping and series tooling.
- Device technology
- Housing design
- Mechanical and mechatronic assemblies
- Actuators, small drives and positioning
- Precision mechanics
- Development of special fans and blowers
- Fixture construction
Documentation / Testing
Product documentation
What use is the best development of a medical device if it cannot be approved afterwards?
To prevent this, our competent experts ensure that the necessary documentation is generated right from the start. This includes not only the creation of meaningful requirements specifications and detailed concept documents, but also the documentation that accompanies the development process. This now accounts for an ever-increasing proportion of the development effort.
With our product documentation, you can go to any approval authority with confidence.
Product testing
For us as a service provider, the quality level of our development results is our top priority. This is the only way we can guarantee our customers that we have developed what they want – and that the resulting product is also approvable.
The area of product testing therefore includes verification of regulatory requirements in addition to verification of our customer’s product-specific requirements. On the one hand, we realize this through tests in our laboratories; on the other hand, we organize and accompany the testing in accredited test laboratories. Thanks to our very good network, we often achieve shorter turnaround times here than has become customary in the meantime. We are also happy to support our customers in validation, be it in usability validation, customer acceptance tests or clinical studies.
Trust in our expertise: Continuous maintenance and improvement of your products
As a full-service provider, we offer you not only the development of your product, but also a comprehensive service after the transfer to production.
- We continuously monitor the market and the availability of electronic and electro-mechanical components.
- By using specialised tools such as Silicon Experts’ Electronic Component Database, we can identify discontinued components at an early stage and avoid supply bottlenecks.
- We endeavour to maintain adequate stocks to ensure smooth production and assembly.
- In cooperation with our development department, we take over the entire discontinuation management for your products.
- We draw up long-term availability plans for all components and develop measures to minimise risk.
- In the event of an emergency, we implement suitable countermeasures to ensure the continuous availability of your products.
- Through early research, we identify alternative components to avoid potential bottlenecks or failures.
- We support you in switching to current, technically standardised components in your products.
- Our experienced team offers technical consulting to identify potential improvements to your product.
- We can help you implement design-to-cost concepts to reduce production costs.
- By analysing components, we can identify potential sources of error and improve functionalities.
Our aim is to offer you continuous availability, improved planning of changes and continuous further development of your products. With our comprehensive service, you can concentrate on your core business while we take care of the challenges of component availability and product improvements.
Contact us to find out more about our services and how we can help you to optimally support your product.