TestLab for medical devices

Development-related testing for medical devices – fast, practical, and compliant with standards. This ensures your medical technology reaches market readiness safely and faster.

Request a product test

Would you like to test your medical device during development?

Or bring a new medical device to market? – But...

Do you lack capacity – be it expertise, personnel or equipment (climate cabinets, ESD chambers and calibrated measuring devices)?
The time pressure to obtain market approval is increasing – but the certification process is complex and confusing?
Do you need independent device testing but can't find a reliable partner with medical technology experience?
Your international manufacturing partner may not meet all German or EU standards?

Testing services for medical devices

In the TestLab you can offer testing and validation services for medical devices as a manufacturer and developer already during development receive. Unlike traditional testing institutes, we test prototypes and development samples for later market entry – reliably, transparently, and in accordance with standards. According to your individual specifications or in accordance with the established, EN ISO 13485 certified processes of MEDtech Ingenieur GmbH.

Security & Reliability: You know whether your product works in real-world use.
Independent tests: You receive objective test results - ideal for internal quality assurance or external verification.
Certification relevance: You receive documented and traceable test results for authorities or customers.
Resource conservation: You avoid having to set up your own processes - you save on personnel and the necessary measuring equipment.

Our services at a glance

In the TestLab, you will receive all relevant tests for medical devices: from functional verification and standard-compliant software tests to EMC and stress tests. We support you throughout your development with our many years of experience in medical technology validation, from the initial idea to approval. This way, we ensure that your medical devices are reliable, safe, and marketable.

Functional tests

Verification of hardware, software and mechanics for systems or individual components
Creation of meaningful test plans and test reports

Carrying out manual tests with measuring equipment
Creation of customer-specific test tools and automated test scripts
Execution of automated tests (e.g. with CANoe, PCAN, Python or other systems)
Ensuring the proper functioning of your medical devices under realistic conditions

Software testing according to
IEC 62304

Verification and validation of softwaresolutions in medical devices
Performance and stability tests for safety-relevant applications
Creation of automated test procedures (including regression and integration tests)
Support with standard-compliant documentation for approval procedures

Security tests

Testing of safety and conformity according to international standards (e.g. DIN EN 60601-1, DIN EN 61010-1, …)
Identification and elimination of potential risks
Determination of the safety of the product

EMC and ESD tests

Analysis and consulting on EMC and ESD problems
Preparation of EMC test plans
Carrying out EMC and ESD precompliance tests (e.g. according to DIN EN 60601-1-2)
Support and technical assistance for external certification tests

Environmental and stress tests

Simulation of environmental conditions (temperature, humidity, ...)
Conducting stress tests and load tests

Advantages of the TestLab

Experience and expertise in medical technology

You benefit from our in-depth expertise and many years of experience in the development and production of medical devices. The testing processes we have established are now available to you as a reliable service.

Customer-specific solutions

Our services are individually tailored to your specific requirements and needs. We support your device development or medical prototypes either selectively or throughout the entire process up to market launch.

Fast test results

Thanks to efficient processes and proven, comprehensive equipment, we provide you with fast and reliable results from medical device tests.

Personal support during the testing process

You will be in direct contact with our test engineer and can discuss potential problems or solutions quickly, easily, and at a professional level – without any bureaucratic hurdles.

Comprehensive test portfolio for medical devices

In our TestLab, you get everything from a single source: We test, advise, and, if necessary, develop suitable solutions to optimally prepare your product for use in medical technology.

References

We value constructive, goal-oriented, and reliable collaboration. This allows us to achieve our goals together within the set framework.

- LRE Medical GmbH

"The collaboration with MEDtech Ingenieur GmbH was extremely professional and efficient. We are very satisfied with the results."

- Siemens Healthineers AG

Eversion Technologies im MEDtech TestLab

"As a young medical technology startup, we benefited enormously from the expertise, reliability, and flexibility of the entire team. The straightforward communication made the collaboration particularly efficient. A clear recommendation—an ideal partner, especially for startups!"

- Eversion Technologies GmbH

Your expert for medical device testing

Leitender Prüfingenieur des Testlabors für Medizingeräte Tests

TestLab for medical devices

Would you like to test your medical device during development?

Testing services for medical devices