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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

In vitro diagnostics (IVD)


We assist in vitro diagnostics companies manufacturing products of all risk classes in obtaining CE marking under the In Vitro Diagnostic Medical Device Regulation (IVDR).



Our services cater to various types of in vitro diagnostic products, such as:

  • immunoassay kits
  • molecular diagnostic tests
  • point-of-care testing (POCT) devices
  • clinical chemistry analysers
  • hematology analysers
  • hematology analysers
  • coagulation analysers
  • microbiology culture systems
  • flow cytometers
  • urinalysis analysers
  • serology test kits
  • general laboratory equipment
    •

We provide support throughout the entire CE certification process. Our services cover a wide range of in vitro diagnostic products of all classes. We assist in the preparation and compilation of all necessary technical and QMS documentation required for your IVD products.

Contact us today to learn more about our CE marking services for in vitro diagnostics under IVDR.

Send us an email:
info@mdrc-services.com

Or use the contact form below