Development of medical devices for diagnostics and therapy makes great demands concerning quality and safety. Since many years Eckelmann is a competent and according to DIN EN ISO 13485:2016 certified innovation partner for hardware and software development in medical device technology. Eckelmann provides time-to-market optimized one-stop-solutions and medical-engineering-services for your product idea:
Product definition and specification
In close cooperation with our customers we prepare the product requirements as well as the technical specification of components and interfaces of the medical device. For new functionalities we create innovative solutions and perform feasibility studies to reduce technical risks.
In this early development stage questions related to operation and usability of the medical device should be addressed and clarified. Eckelmann supports this by usage of - partly in-house developed - tools for creation of control procedures and simulation of graphical user interfaces.
Agile development strategies
The application of agile development procedures can siginificantly shorten your time-to-market. Agile approaches like SCRUM hereby support the iterative creation of specifications and enable an early stage evaluation of realization concepts and usability involving the customer. For this purpose Eckelmann applies proceedings listed below for rapid system prototyping:
- Simulation of graphical user interfaces GUI and control elements
- Simulation of menu navigation
- Simulation of operation sequences (state-machine)
- Model based software development according to UML
- Circuit and functional simulation using MATLAB/SIMULINK
- Functional hardware models based on PC, PLC, FPGA oder µC platforms; in-house production of PCBAs
- Rapid-Prototyping for housings and control elements supported by our design partners
According to the requirements already specified our interdisciplinary engineering teams draft system architecture and software architecture of the medical device, from which the required hardware and software components become evident. The design planning always considers requirements for testability and manufacturing that are essential for the subsequent production.
Our highly experienced electronics engineers develop the required analogue and digital circuits and create the PCB layout. As a matter of course the development follows the relevant standards for electrical safety as well as electromagnetic compatibility (EMC).
Regardless of which hardware platform is chosen for realization of your medical device: according to DIN EN 62304 our software engineers develop the appropriate code for embedded µC, FPGA, PC or PLC. For this purpose different development tools are available.
In cooperation with our network of design partners we coordinate the housing design and integrate electronic and mechanical assemblies.
Software and hardware components will be tested on unit level first. After system integration verification tests based on already existing integration test plans will be performed to assure that the system performance meets all of the technical requirements.
Support of validation and accreditation activities
We gladly support your validation testing to be performed under responsibility of the company placing the medical product on the market. As a consutlant we accompany you during the accreditation activities for your medical device.
Production engineering, electronics assembly, and final assembly, functional testing
We transfer your medical deviceto serial production and take responsibility for stock management as well as planning of assembly & test. In serial production for our customers we offer reliable just-in-time delivery services including disposability management:
- Monitoring of component disposability
- SMD and THT PCB assembly
- Manufacturing of prototypes, pre-production assemblies, serial production of small and large series
- Stocking of standard and key components
In serial production we perform final assembly and test and provide the complete device history records.
Automated assembling and testing equipment
On request we develop and manufacture automated assembling systems and testing equipment required for quality assurance in serial production. In case your production shall be launched in any global facility we carry over the installation, commissioning and qualification (IQ,OQ) of the production systems on-site. In this regard Eckelmann has long term experiences - also with production or therapy facilities located in China - and is a certified switch cabinet manufacturer as well (UL-File E233027).
After sales service
Our engagement does not necessarily end up with the achieved product acceptance test. Eckelmann gladly supports you with maintenance activities such as:
- Product improvements based on information from field application
- Implementation of change requests
- Component discontinuation management
- Software support and maintenance
- Service tools development
- Second-source research and testing
- Measures for reduction of production costs
- Services for maintenance, repair and modification
- Optimization of production and testing processes
Quality management and risk management
The entire development process up to manufacturing is enveloped in our quality management system according to DIN EN ISO 9001:2015 and EN ISO 13485:2016 and is accompanied by a continous risk management process according EN ISO 14971. The measures identified in risk analysis and FMEA are incorporated into the requirement specifications and will then be implemented into the design by our development engineers.
In addition to the examination and mitigation of harms that might effect the user we provide consultancy for prevention of technical risks that might be opposed to a successful development or marketing.
The involvement of our customers in the development process as well as transparency and frankness are - from our experience - important contributions to the success of the medical device development. Our internationally experienced project managers coordinate the development activities as well as the quality and risk measures. The are furthermore main contact person for our customers at any time. An intense dialogue keeps you informed about the development progress and enables you to exert influence on the development process.