Mikroskopische Untersuchung im Prüflabor

Welcome at the senetics Prüflabor – Test lab!

Testing the developed product is an essential part of the product development and approval. From user testing to biomedical validation, we can test and validate your products in a variety of possibilities.

Standard compliant tests ensure quality!

We support you in the development and production phase. We evaluate your products from prototype to certification. Our test lab tests your products for ergonomics as well as electrical, mechanical and functional safety. In addition, we offer environmental tests and IP protection class tests.

The approval process requires extensive testing to ensure, for instance the serviceability or the functional safety of the products.

Testing for your medical device

A medical device may only be placed on the market or put into service if they are CE marked. The CE marking may be affixed if the products meet the Essential Requirements and the prescribed conformity assessment procedure has been carried out. The Essential Requirements are set out in the relevant Annex I to Directives 90/385 / EEC (Active Implantable Medical Devices), 98/79 / EC (In Vitro Diagnostic) and 93/42 / EEC (Other Medical Devices). Depending on the medical device, different tests must be carried out in a certified test lab.

Areas of application:

  • Checking product safety and improving product shelf life
  • Documentation check and risk minimization measures
  • Optimization of product properties, for example,
    • Abrasion resistance, UV stability
    • Tensile strength of catheters, pressure loading of tooth rails

Normative tests, for example:

  • Functional safety according to EN 60601-1
  • Scratch test with microscopic analysis according to DIN EN ISO 1518-1
  • Safety of software and PEMS according to IEC 62304
  • Usability test according to IEC 62366
  • Testing cardiovascular implants according to ISO 7198
  • Testing of rigid endoscopes according to EN 60601-2-18

Customized tests:

  • Load test for UDI labels
  • Automated endurance tests on control panel with microscopic analysis
  • Realistic germ load test of respirators
  • Proof of the effect of disinfectant during nebulization
  • Ex-vivo skin models for testing innovative vital parameter sensors

 

The team of the senetics Prüflabor – Test lab is looking forward to your inquiry!

 

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