Performance evaluation studies

Performance evaluation studies

  • Cutoff determination
  • Analytical and diagnostic sensitivity/specificity
  • Feasibility studies (within-run precision, limit of blank, dilution linearity, %recovery, sample carryover)
  • Studies in accordance with "MPG-DIN ISO 14155" (Ethics committee, patient consent, site selection and contracting)

Validation

  • Freshly drawn blood samples
  • Precision
  • Detection limit, LoB
  • Method comparison
  • Linearity
  • Sensitivity
  • Calibration stability, Onboard stability
  • Cross-reactons, interference
  • Internal lab precision (day-to-day precision)
  • Module and analyzer precision
  • Reproducibility (lab, user)
  • Stability testing after freeze thaw-cycles
Clinical performance studies

Clinical performance studies

  • to assist in obtaining CE mark acc. to CTS for Annex II, list A products
  • To assist in scientific validation
  • Analytical and clinical performance evaluation studies
  • Provision, supervision, support or implementation of reference tests
  • Creation and evaluation of anamnesis data
IVDR und CTS

IVDR und CTS

  • Scientific validity reports
  • Analytical performance evaluation studies
  • Clinical performance evaluation studies
  • Support in generating the Technical Dossier
  • Implementation of PMS plans and reports (Post-Market Surveillance) 
  • Consulting and support in the introduction of the UDI (Unique Device Identification)
  • Support for the approval of IVDR compliant products
  • Communication with the Notified Bodies
Prospective sample collection

Prospective sample collection

  • Provision of precisely defined samples for prospective studies
  • Quantitative and qualitative documentation of prospective samples according to the analytical and serological requirements of the tests
  • Delivery of bulk material is possible
  • Human samples with different stages of infection available for antibody detection (seroconversion samples)

IVDR / CTS

Since May 25, 2017, the EU Directive 98/79/EC has been replaced by the European Regulation for In Vitro Diagnostics (IVDR). In contrast to the Regulation for Medical Devices (short: MDR), which must be implemented as early as May 2020, the IVDR is only mandatory after a five-year transition period. But the time buffer is smaller than it seems. Those who do not take care of the necessary validations, performance evaluations and documentation now will no longer be able to market their diagnostics in compliance with the law from May 26, 2022. The regulation makes no distinction between new products and diagnostics already on the market, i.e. there is de facto no protection of existing products and manufacturers must assess, check and, if necessary, validate all products for their risk class.

 

Biomex GmbH offers support and a wide range of services and reference samples for the timely and standard-compliant implementation of the IVDR specifications:

  • classification of your products and definition of the resulting requirements and certification tasks
  • More than 450,000 human biological stock samples for validation and quality control of your assays and sera
  • Support in communication with the Notified Bodies required for accreditation and assistance during the conformity assessment procedure
  • Planning and implementation of a special unique Product Identification Number (UDI) for the secure traceability of a product within the supply chain
  • External execution of studies or internal support in the preparation of necessary clinical studies
  • Support in the adaptation of technical documentation according to IVDR requirements including continuous performance evaluation