IVDs and Companion Diagnostics Testing and Certification

UL International Germany GmbH

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The European In-vitro Diagnostic Medical Devices Regulation 2017/46 (IVDR) specifies ergonomics and usability as part of the General Safety and Performance requirements. Our usability engineering experts can help manufacturers prepare the required usability data to demonstrate compliance with IVDR.
UL offers the following services to IVD manufacturers:

  • CE Marking (via our Notified Body partner, PCBC)
  • Auditing (ISO, MDSAP, NB)
  • Batch verification
  • Sterilization
  • Biocompatibility
  • Testing and certification
  • Electrical, Fire and Mechanical safety testing
  • Refrigeration testing for related laboratory equipment
  • Electromagnetic compatibility
  • Usability

In addition to new devices, our team of tenured biomedical engineers and experts are able to support refurbishment of IVD immunoassay analyzers and sample dispensers. Our field service engineers can help with Quality Management System (QMS) compliance for contract manufacturers of IVD reagents, antibodies and test kits. Per quality requirements, we are also able to provide certification services to IVD manufacturers who do installation and preventative maintenance of IVD analyzer systems and software as well as resale transaction conformity and supply chain traceability.

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