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Testing Services

Medical Device Testing

We specialize in creation and execution of device verification and performance testing plans to support developments and regulatory submissions.  Testing is performed according to ISO, EN, DIN, ASTM and applicable regulatory standards, including FDA requirements (e.g., 510(k) submissions, IDE applications, etc.).  The majority of tests are performed in-house.  For selected laboratory tests, such as biocompatibility, sterility, particulates, conditioning (e.g., aging, environmental, transport, etc.), and package integrity, CMI collaborates with external partners.

In-house Capabilitites

  • Test for peak tensile force
  • Test of strength of union
  • Test for liquide leakage under pressure
  • Luer Gauge Test acc. ISO 594
  • Test for air leakage during aspiration
  • Test for kinking
  • Test for fracture of guidewires
  • Test for pinholes in plastic laminate
  • Dye Penetration Test
  • Packaging Burst Testing
  • Conformity Testing for Conical fittings
  • Image Dimension Measurement

Location

Contract Medical International GmbH
Lauensteiner Strasse 37
01277 Dresden, Germany    

Contract Medical International, spol. s r.o.
Vazni 848, 500 03 Hradec Králové
Czech Republic

get in touch | send applications to

tel. +49 351 213 88 88 | fax +49 351 213 88 99
info@contract-medical.com

Dresden: jobs@contract-medical.com
Hradec Králové: jobshk@contract-medical.com

projects are supported by the eu