Testing

Error-Free Medical Devices can Save Lives

That is why we test important product requirements with precise and reliable tests.

‘Laboratory’ is invenio's physical-technical testing technology, with a focus on the areas of evaluation and approval-relevant tests (verification).

The testing of medical devices takes place in the environment of our DIN EN ISO 13485 certified quality management system. Our spectrum includes:

01

Design of experiments

02

Method Development and Method Validation

03

Equipment Qualification

04

Preconditioning

05

Test Procedure

06

Evaluation

07

Root Cause Analysis in case of deviations as well as feedback of the findings in the development

08

Documentation

Laboratory Climatic chamber

Tests are not always defined by standards, for example. Therefore, another focus of our laboratory activities is the development of new, product-specific test methods including the required equipment. Through the close exchange between developers, method experts and testers, we create very efficient workflows.

  • Method Development

  • Method Validation

  • Development of special Testing Equipment

  • Automated evaluation, e.g. with software Minitab

  • ZWICK programming (testxpert)

  • LabVIEW

  • Inspection plan

  • Instruction of the employees

  • Qualified equipment

  • GMP-compliant documentation Review (4-eye principle)

  • Evaluation and Verification tests

  • Product analysis and optimizationg

  • Determine critical characteristics

  •  Statistical methods for quality assurance, Design of Experiments (DOE)

  • Recommended action

We are constantly expanding our existing equipment. Do not hesitate to ask!

  • ZWICK tensile / compression testing machine including torque measurement

  • Force Sensors

  • Displacement

  • Coordinate measuring machine 

  • Accelerometers

  • Pressure Sensors

  • Precision Balances

  • Vibration Tester (Shaker)

  • Measuring devices for noise measurement and characterization

  • Solar simulator (Xenon)

  • Storage Cabinets

  • Dust Chamber

  • Media Baths

  • pH Meter

invenio designs and manufactures for you in-house:

  • Receiving Adapter

  • Manual Test Devices (jigs)

  • Turnkey testing machines (full and semi-automatic machines)

  • Image Processing and Evaluation Systems

  • ZWICK Test Specifications (programming)

  • Measuring System Analysis according to MSA

  • Equipment Qualification

Would You like to contact us?

Gladly we are at your disposal for any questions! 

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