Performance Evaluation

1. Scientific validity
1.1 Pre-Market

  • Scientific literature (peer reviewed)
  •  Consensual expert appraisals/expert statements from relevant specialist organizations
  • Results of proof of concept studies
  • Results from clinical performance studies

1.2 Post-Market-Surveillance (PMS)

  • Proactive data collection
  • Evaluation of performance data
  • Latest technology - state-of-the-art

2. Analytical performance
2.1 Analytical sensitivity

  • Detection and quantification limits (LoD, LoB, LoQ)
  • Linearity
  • Measuring range (defined by LoQ and linearity)

2.2 Analytical specificity

  • Cross-reactions (analytes with similar structures, such as precursors, metabolites, related organisms)
  • Interferences (hemoglobin, icteric, lipemic, RF +, HAMA, ...) 

2.3 Stability studies for assays and samples

  • Sample type, matrices, sample stability, storage conditions, freeze-thaw process
  • Calibration stability, onboard stability
  • Module and device precision

2.4 Trueness (distortion)

2.5 Precision

  • Repeatability (day-to-day measurement)
  • Reproducibility (laboratory and user)

2.6 Accuracy (as a result of trueness and precision)

3. Clinical Performance Evaluation
3.1 CTS/CS

  • Diagnostic sensitivity
  • Diagnostic specificity
  • Positive predictive value
  • Negative predictive value
  • Likelihood ratio
  • Expected values ​​in affected and unaffected population groups

3.2 Near-Patient Testing (NPT)

  • Conformity assessment according to Annexes IX to XI IVDR
  • Evaluation of the technical documentation

3.3 Lay studies
To apply for special approval for an in-vitro diagnostic test for self-use by laypeople

Customer Specific Solutions

1. Operation of COVID-19 rapid test centers

  • Planning and implementation
  • In accordance with the requirements of the Covid Occupational Safety and Health Ordinance (current version)
  • on their company premises within Germany

2. External study site

  • Implementation of clinical performance evaluation studies
IVDR Conformity / CTS

Implementation of the IVDR requirements

  • Classification of the product
  • Definition of certification tasks
  • Support during the conformity assessment procedure
  • Unique Device Identification (UDI)
  • GAP analysis
  • Technical documentation
  • Post-Market-Surveillance (PMS)
  • Communication with notified bodies
Prospective Sampling

Prospective sample collection

  • Provision of precisely defined samples for conducting prospective studies
  • Quantitative and qualitative documentation of the prospective samples in compliance with the analytical and serological requirements of the tests
  • Supply of bulk material
  • Human samples at various stages of infection available for antibody detection (seroconversion panels)

Unique Device Identification (UDI)

With the introduction of a new device identification number (UDI), new labeling obligations have arisen that go way beyond what is required today. With the UDI labeling, the EU intends to be able to track medical devices quickly and easily - from the manufacturer to the user. This allows for a quick response in the event of incidents, as on the one hand products are easier to identify (down to the individual device, batch or software version) and on the other hand the location of the devices can be tracked and thus the users can be located faster and more specifically. This also mean that medical devices that are marketed illegally can be tracked down more easily.

Here, too, Biomex GmbH is happy to assist manufacturers in planning and implementing a UDI for the secure traceability of a device within the supply chain. Contact us!

Unique Device Identification (UDI)

Mit der Einführung einer neuen Produktidentifizierungsnummer (UDI) ergeben sich neue Kennzeichnungspflichten, die weit über das heute Geforderte hinausgehen. Die EU möchte durch die UDI-Kennzeichnung Medizinprodukte schnell und einfach nachverfolgen können – vom Hersteller bis zum Anwender. Dies erlaubt es bei Zwischenfällen schnell zu reagieren, da zum einen Produkte einfacher zu identifizieren sind (bis hinunter auf das einzelne Gerät, den Batch oder eine Software-Version) und zum anderen der Standort der Geräte nachvollziehbar ist und damit die Anwender schneller und spezifischer auffindbar sind. Des Weiteren können illegal vermarktete Medizinprodukte leichter gefunden werden.

Auch hier assistiert die Biomex GmbH Herstellern gerne bei der Planung und Implementierung einer UDI zur sicheren Rückverfolgbarkeit eines Produkts innerhalb der Lieferkette. Sprechen sie uns an!