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)

Post-Market-Surveillance (PMS)

Before launching products onto the market, manufacturers must minimize possible risks from their products and ensure the safety of patients. However, some risks will only become apparent over time if the products are used on a daily basis. Post-market-surveillance, i.e. surveillance after it has been launched on the market, has the following objectives - it should:

  • check the performance of the products in use
  • identify product defects and previously undetected safety issues
  • systematically identify potential risks with the practical usage of the product
  • continuously update the benefit-risk assessment
  • rapidly initiate necessary measures, such as issuing recalls.

In brief, PMS or continuous performance evaluation entails the proactive, systematic and continuous monitoring of a product after the manufacturer has placed it on the market. This allows manufacturers to ensure that the products deliver the promised benefits to patients and that there are no uncontrollable risks.

Biomex supports manufacturers in the planning and implementation of their post-market-surveillance. Contact us!

Post-Market-Surveillance (PMS)

Hersteller müssen, bevor Sie Produkte in den Markt bringen, mögliche Risiken durch ihre Produkte minimieren und die Sicherheit der Patienten gewährleisten. Allerdings offenbaren sich einige Risiken erst im Laufe der Zeit, wenn die Produkte täglich eingesetzt werden. Die Post-Market Surveillance, also die Überwachung nach dem Inverkehrbringen, hat folgende Ziele - sie soll:

  • die Leistungsfähigkeit der Produkte bei der Anwendung überprüfen
  • Produktfehler und bisher unentdeckte Sicherheitsprobleme finden
  • mögliche Risiken beim praktischen Gebrauch des Produktes systematisch identifizieren
  • die Nutzen-Risiko-Bewertung kontinuierlich aktualisieren
  • notwendige Maßnahmen, wie Rückrufe schnell einzuleiten.

Kurz, unter PMS oder kontinuierlicher Leistungsbewertung versteht man die proaktive, systematische und kontinuierliche Überwachung nach Inverkehrbringen durch den Hersteller. Dadurch können Hersteller gewährleisten, dass die Produkte den Patienten den versprochenen Nutzen bieten und keine unbeherrschten Risiken existieren.

Die Biomex unterstützt Hersteller bei der Planung und Durchführung ihrer Post-Market-Surveillance. Sprechen sie uns an!