Functioning and flawless medical devices are vital for patients. We test important product requirements with precise and reliable medical device tests in our in-house medical technology test rooms.
This is where we carry out our physical-technical testing technology, focussing on the areas of evaluation and approval-relevant tests (design verification).
Medical device testing at invenio takes place within the framework of our DIN EN ISO 13485-certified quality management system. However, tests are not always defined by standards, for example. Therefore, another focus of our activities is the development of new, product-specific test methods including the required equipment (method development). Through close dialogue between developers, method experts and testers, we create very efficient workflows in medical device testing in medical technology.
With our test equipment, we can carry out extensive tests in the field of medical device testing. This enables us to simulate various types of material stress (material testing), such as intensive mechanical stress (mechanical testing) – for example bending and long-term stress (durability testing, accelerated testing). In our climatic chambers, we subject electronics to endurance tests and environmental tests as well as accelerated durability tests. In addition to material stress, we test medical devices for other properties such as operating forces and dosing accuracy. This ensures high-quality medical devices that are safe to use.
- Conceptualisation
- Validation
- Development of special test equipment
- Automated evaluation, e.g. with Minitab software
- ZWICK programming (testexpert)
- LabVIEW
- Test plan creation
- Instruction in special test equipment
- Qualified equipment
- GMP-compliant documentation
- Document creation
- Document review
- Report generation
- Evaluation and design verification reviews
- Evaluation of results
- Product analysis and optimisation
- Determination of critical features
- Statistical methods for quality assurance, design of experiments (DOE)
- Recommendation for action
- Analysis and optimisation of existing test methods
- ZWICK tensile/compression testing machine including torque measurement
- Force sensors
- Displacement sensors
- Coordinate measuring machine
- Acceleration sensors
- Pressure sensors
- Analysis and precision scales
- Vibration test stand (shaker): Generates vibrations in different levels and variations to ensure optimum
- transport simulation
- Measuring devices for noise measurement and characterisation
- Environmental testing: sun simulator (xenon), climate chambers, dust chamber
- Media baths
- PH value measuring deviceWe are constantly expanding our existing equipment. Please do not hesitate to enquire!
invenio designs and manufactures for you in-house:
- Mounting adapters
- Manual testing device (jigs)
- Turnkey automatic testing machines (fully and semi-automatic)
- Image processing and evaluation systems
- ZWICK testing device (programming)
- Measurement system analysis according to MSA
- Device qualification
Software Testing in Medical Technology
We rely on test automation for comprehensive and efficient testing of your medical device software. We utilise both industry-specific standard tools and automation solutions developed in-house. The test results are then entered into Polarion® ALM™ to ensure the traceability of the original requirements and their fulfilment.
Your Contact to our Experts:
Martin Tschuch
Head of Competence Centre
Embedded Systems & SW-Solutions
invenio Engineers Karlsruhe GmbH
Unterweingartenfeld 6
76135 Karlsruhe
Contact me
P +49 (721) 626958-490
M +49 (176) 11899271
Leo Zeimetz
Head of Business Unit
Product and System Development
invenio GmbH Engineering Services
Eisenstraße 9
65428 Rüsselsheim am Main
Contact me
P +49 (6142) 899-247
M +49 (172) 6638452
Stephan Drozniak
Managing Director
invenio Healthcare Solutions GmbH
invenio Healthcare Solutions GmbH
Sossenheimer Weg 32
65824 Schwalbach am Taunus
Contact me
P +49 (40) 1806571-51
M +49 (178) 4571675
Would You like to contact us?
Gladly we are at your disposal for any questions!
