Whether the ECG device complies with functional safety requirements, whether the controls and surface materials used in the vital signs monitor have the planned service life, or whether a ventilator can be disrupted by electromagnetic effects – all of this must be checked in complex tests. The scope of test procedures and scenarios is huge, and demand is high. However, only very few testing service providers can offer a truly comprehensive range of services. One of the exceptions is the EDAG Group, which makes its locations virtually accessible.
Doctors and nursing staff rely on their equipment to function reliably in their daily work with sick and elderly patients. Malfunctions or even failures could damage health or even threaten the lives of those affected. The requirements for medical devices are correspondingly high – both in terms of legal requirements and customer expectations.
Manufacturers of medical devices therefore invest considerable effort in ensuring the quality and reliability of their products. At the same time, they are under enormous competitive pressure in terms of both development costs and innovation. Market success is also determined by factors such as efficient operating costs and added value in optimizing customer work processes.
Testing plays a significant role in achieving these wide-ranging development goals – and the range of test procedures and scenarios is correspondingly broad. They range from physical and technological tests to functional tests of hardware and software to electromagnetic compatibility (EMC) testing. Specialized service providers can be found for all these tasks, who have both the equipment and the necessary expertise to carry out standardized test procedures.
Risks for the development process
Testing is therefore a fundamental part of the development process. However, testing tasks cannot be arbitrarily divided among different service providers. This is because the various development goals often compete with each other. For optimal results, a viable compromise must therefore be found – and the testing tasks associated with the respective objectives must be handled by a single provider. Otherwise, there is a risk of friction losses, which would be accompanied by increased communication costs, additional expenses, and delays in development.
Many testing service providers offer a comprehensive range of services. However, there is often a dividing line between physical-functional testing and EMC testing – most providers can deliver either one or the other. This means that you either have to accept the aforementioned friction losses in the development process or put EMC testing on the back burner. However, this is a risky strategy. If problems with the electrical or electronic systems arise later on, this can lead to costly rework or even setbacks in development. It is therefore better to choose a testing provider that can deliver everything from a single source.
360° testing service
The EDAG Group, a provider of all kinds of engineering services, has overcome this divide. The "Testing Germany" department brings together test laboratories at six locations in Germany and one laboratory in Mexico. In addition to Fulda, where the company headquarters are located, there are test laboratories in Böblingen, Ingolstadt, Munich, Wolfsburg, and Recklinghausen.
Each of these locations has different test systems, such as climate chambers, heat ovens, shakers, and temperature shock systems. There are also systems for testing various IP protection classes, for sun simulation, and for robot scenarios. Fulda is also home to a modern EMC center, which includes EMC absorber halls and an EMC shielded cabin (pulses, ESD). This enables EDAG to offer a complete 360° test environment that meets all requirements. Not only for the medical device industry, but also for automotive, consumer electronics, and industrial applications.
Proven expertise and quality
The EDAG Group's test sites are now accredited by the German Accreditation Body (DAkkS) for around 20,000 specific test procedures from many different industries, including the medical device industry. In addition, flexible accreditation has also been granted. This means that in cases where accreditation for a specific standard is not available, but is available for a similar standard, EDAG can refer to the latter. Furthermore, additional test procedures are also included as part of the annual renewal of accreditations if there is relevant customer interest.
EDAG Group customers have access to the digital EDAG Mobility and Industry Shop, which provides an overview of the accredited testing services for systems, prototypes, and components. There, you can request tests from various test categories, such as material testing, environmental simulation, functional testing, or EMC, directly online.
Fig. 2: Here is an example of the virtual tour of the EMC center in Fulda.
For those interested in learning more about the test locations and the equipment available, the EDAG Group has also set up virtual tours of its testing locations, including the EMC Center. This allows you to get a detailed overview of the options available with minimal effort.
Central test part logistics
In order to make processing as efficient as possible, the EDAG Group has set up its own logistics system for testing orders. Customers send the test specimens to a central address in Kassel, from where just-in-time delivery to the test locations is guaranteed. At the same time, the central test part logistics system meets all requirements for prototype protection. On request, the test part logistics department also provides additional services such as long-term storage or collection directly from the customer. The EDAG Group also makes every effort to ensure data security – both its own and that of its customers – as reflected, for example, in its ISO/IEC 27001:2022 certification.
With their extensive know-how of products, markets, and validation processes, EDAG's experts can not only provide assistance in carrying out standardized testing processes and interpreting the results, but also develop new testing procedures for innovative technologies, take on development tasks resulting from the test results, or provide comprehensive support in the approval process for medical devices, both in the EU and in the USA under the supervision of the Food & Drug Administration (FDA).
Do you also need support with testing in the areas of physical and technical testing as well as EMC? Then talk to our expert Christian Walter, Senior Sales Manager Specialist Sales Testing Germany at the EDAG Group. Or download our white paper "Full-service testing for medical devices" right here, which provides you with further details on the advantages of a 360° full-service provider.
