in.vent Clinical Services (ICS) of Hennigsdorf at MEDICA 2020 in Düsseldorf -- MEDICA - World Forum for Medicine
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in.vent Clinical Services (ICS)

Postfach 16761, 16761 Hennigsdorf
Neuendorfstraße 17, 16761 Hennigsdorf
Germany

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This company is co-exhibitor of
DiagnostikNet-BB

Contact

Dr. Karl Lewin Günther

Head of in.vent Clinical Services

Phone
+49330255199550

Email
L.Guenther@inventdiagnostica.de

Our range of products

Product categories

  • 03  Diagnostic tests
  • 03.07  Other diagnostics

Other diagnostics

  • 07  Medical services and publications
  • 07.01  Reports and analyses

Our products

Product category: Reports and analyses

Clinical Performance Studies

A Clinical Performance Study assesses the ability of a device to deliver results that correlate with a certain clinical condition.

Strictly following the IVDR and ISO 20916:2019 we will plan, conduct and report this study for you:

  • Application to an ethics committee
  • Sample procurement
  • Clinical Performance Study Plan according to ISO 20916 and IVDR, annex XIII, part A
  • Study site recruitment and monitoring
  • Study conduct
  • Statistical analysis
  • Clinical Performance Study Report according to ISO 20916 and IVDR, annex XIII, part A
 

While our service comprises the whole process of Clinical Performance Studies from A to Z, you may freely choose which particular services you need.
We will adapt our quotation accordingly.

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Product category: Reports and analyses

Analytica Performance Studies

An Analytical Performance Study assesses the ability of a device to correctly measure the corresponding analyte. 

Using state-of-the-art approaches and following the corresponding guidelines (e.g. CLSI) we will take care of all necessary steps: 

  • Procurement of samples
  • Assessment of all parameters described in IVDR, annex I, Section 9.1, point (a)Detection and quantification limits
  • Intererences and cross-reactivity
  • Trueness (Bias)
  • Precision (Repeatability and reproducibility)
  • Measuring range
  • Linearity
  • Cut-off
  • Specimen collection and handling criteria
  • Generation of the Analytical Performance Study Report according to IVDR, annex XIII, part A.
 

For Analytical Performance Studies we cooperate with our trusted partner Future Diagnostics!

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About us

Company details

The IVDR 2017/746 has caused a veritable earthquake within the in-vitro diagnostic industry. The new requirements regarding verifiable clinical evidence, ethical coverage, and meticulous reporting put a strain especially on small- to medium-sized enterprises, and thereby on the European IVD market itself. Our goal is to help companies cope with this challenge in order to avoid the predicted dwindling of this essential industry in the EU.

Your advantage: With ICS you have all in one hand!

We take care of every step of IVD validation, from ethics to samples to performance studies. 

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Company information as a PDF file