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Technical File
Technical Services for MDR and IVDR

A Technical File is proof that a medical device complies with the essential
safety and health requirements set down by the relevant Directive(s).

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Find all Medical Device Regulations MDR & IVDR

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Email: [email protected]

T: 32 (0)2 732 72 92

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About Us

GiDoS SPRL is a quality driven, service-oriented regulatory affairs company, located in Brussels, Belgium. Our main service area is in the medical sector, with a focus on Medical Devices and In-Vitro Diagnostics.

>> OUR INDUSTRIES

  • Medical Devices
  • IVDR

>> OUR SERVICES

  • Technical file
  • Clinical Evidence
  • Risk management
  • Borderline classification
  • Gap assessment