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TESTING


We rely on exact processes – for a traceable and consistently high quality. For this purpose, our quality management system is certified according to DIN EN ISO 13485

With regards to the reliability and quality of the products, all medical technology companies are specifically committed to their customers. Our Testing Team is aware of this responsibility and meets this requirement with specific, comprehensive process documentation and the corresponding risk management. At the verification stage, we also demonstrate the reliability of tests through a structured method validation. These secured results support the acceptance process of the products. All verification activities are carried out in our own laboratory in accordance with our DIN EN ISO 13485 certified quality management system.

For a reliable testing, we strictly adhere to predefined processes. For compliance with the safety criteria of the medical tests, we strictly follow our standard processes (SOP – Standard Operating Procedure). We ensure the comprehensive documentation of all relevant test results and features – from the request for quotation up to the conclusion of the whole project.

Our services at a glance:

  • A company-owned Lab with Precision Measurement Equipment
  • Development and Testing
  • Development and Use of Measurement Devices and Measurement Methods


We use high-precision scales with a display precision of up to one microgram as well as an exact Zwick mechanical tensile/pressure testing machine for the force-displacement recording, or torque, angle, characteristics curves, respectively. Apart from the tests we also offer related services, e.g. the development, preparation and qualification of test equipment (so-called jigs) or complete specific test devices in case the standard test equipment does not meet the requirements.

You do not have your own lab or would like to enhance your in-house capacities?

We are the right partner for you with regards to*:

Test Method Development

Test Method Development

The reliability of a product plays a key role in the medical technology field – any doubt can even put the life of people at risk. Also, test methods must be safe. A structured testing method is decisive and has a great impact on the later results. For this purpose, we plan the test during the development stage, and define the specific requirements and corresponding tests in accordance with these specifications.

Our services at a glance:

  • Test Planning and Timing
  • e test whether a test method is already defined by the standards
  • Elaboration and Documentation of new test methods
  • Research of Test Equipment
  • Development and Manufacturing of special Test Equipment (you find more information on test technology and automation on ourmain site)
  • Qualification of test equipment
  • Validation of test methods in accordance with e.g. Gauge R&R (Gauge Repeatability and Reproducibility)
  • Care, Maintenance and Recalibration of Test Equipment and Documentation

Development and Evaluation Tests

Development and Evaluation Tests

Each product must comply with all requirements of the Requirement Specification without fuss or quibble. With the aid of functional prototypes – manufactured with prototype procedures or already from tools – the corresponding tests are performed. The close interconnection of our teams in the Development, Production and Testing processes under one roof is a great asset.

Our services at a glance:

  • Preparation of Tests
  • Training of the employees in the relevant test methods
  • Conditioning of test samples
  • Test performance in accordance with test protocol and collection of raw data
  • Test valuation
  • Documentation in the form of test reports
  • Identification of any optimization potential and transfer to the Product or Process Development

Verification Tests

Verification Tests

In view of the clinical studies or market authorization, we perform verification tests in accordance with DIN EN ISO 13485:2012. Our specialist staff qualifies the required test equipment and validates the corresponding methods. In view of its significance, we always coordinate the detailed procedures with our customer in advance.

Our measurement and test equipment allows for, e.g.:

  • Pre-conditioning of prototypes
  • Obtaining the dosing precision or the volume flow by means of precision gauges
  • Determining tensile and pressure forces within a scope of 0 N to approx. 2500 N
  • Determining torques within a scope of 0 Nm to approx. 5 Nm
  • Drop tests with start position and start height
  • Determining energy consumption for e.g. mechatronic transmission and pump systems or electronic components
  • Testing of component characteristics curves, e.g. for sensors or actuators
  • Tests with special test equipment


*For a detailed description please select the desired subject field

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