Functioning and flawless medical devices are vital for the survival of patients. We test important product requirements with precise and reliable medical device tests in our in-house medical technology test rooms.
Here we carry out our physical-technical testing technology, with a focus on the areas of evaluation and approval-relevant tests (design verification).
Medical device testing at invenio takes place in the environment of our DIN EN ISO 13485 certified quality management system:
Design of Experiments
Method Development and Method Validation
Equipment Qualification
Preconditioning
Test Procedure
Evaluation
Root Cause Analysis in case of deviations as well as feedback of the findings in the development
Documentation
Design Verfication
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 necessary equipment (method development). Through the close exchange between developers, method experts and testers, we create very efficient workflows in medical device testing.
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Conceptual design
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Validation
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Development of special Testing Equipment
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Automated evaluation, e.g. with software Minitab
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ZWICK programming (testxpert)
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LabVIEW
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Test plan creation
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Instruction of special test equipment
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Qualified equipment
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GMP-compliant documentation Review
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Document creation
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Document review
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Reporting
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Evaluation and design verification tests
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Evaluation of results
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Product analysis and optimizationg
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Determine critical characteristics
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Statistical methods for quality assurance, Design of Experiments (DOE)
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Recommended action
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Analysis and optimisation of existing test methods
With our product range, we can carry out extensive tests in the area of medical device testing. This means that various types of material stress (Material Testing), such as intensive mechanical stress (Mechanical Testing) – for example bending and continuous stress (Durability Testing, Accelerated Testing) – can be simulated. In addition to material stress, we test medical devices for other properties such as operating forces and dispensing accuracy. This ensures high-quality medical devices that are safe to use.
With the help of our equipment, various medical device testings and specific measurements can be carried out.
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ZWICK tensile/compression testing machine including torque measurement
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Force Sensors
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Displacement Sensors
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Coordinate measuring machine
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Accelerometers
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Pressure Sensors
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Analysis and precision scales
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Vibration test rig (shaker): Generates vibrations in different levels and variations to ensure optimal transport simulation
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Measuring instruments for noise measurement and characterisation
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Environmental testing: solar simulator (xenon), climate chambers, dust chamber
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Media baths
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PH-value measuring device
We are constantly expanding our existing equipment. Do not hesitate to ask!
invenio designs and manufactures for you in-house:
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Receiving Adapter
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Manual Test Devices (jigs)
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Turnkey testing machines (full and semi-automatic machines)
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Image Processing and Evaluation Systems
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ZWICK Test Specifications (programming)
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Measuring System Analysis according to MSA
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Equipment Qualification
Would You like to contact us?
Gladly we are at your disposal for any questions!
