The training includes two stages:
1. The stage of knowing the device
2. The stage of knowing the software
listing medical bulletins
solving minor problems
-control sera are tested
-patient sera are tested
We have a great deal of flexibility in providing technical support, so that the problem can be solved in the shortest time.
Technical support is provided by telephone and in certain situations TeamViewer is used to remedy any problems or ambiguities you encounter in the use of laboratory equipment.
We travel to your lab in 24-48 hours *.
* This deadline may be exceeded in exceptional cases.
The best solutions are provided to remedy the problems and clarify the way of working with the device / software in the shortest time;
We perform electrical safety tests for analyzers.
Training for the use of in vitro diagnostic kits sold by DDS Diagnostic: The training has both a theoretical and a practical part in which you have the opportunity to familiarize yourself with good laboratory practices but also with working methods for electrophoresis, ELISA, CLIA or quick tests.
Technical assistance for the preparation of the documentation requested by RENAR
Quality certificate / values for control sera
Service intervention sheets
Analyzer programming steps
Instructions for use
IVD kits and reagents are expected to provide accurate results that are reliable and meet the intended purpose. In many countries, national requirements set high standards of quality and safety for in vitro diagnostic medical devices to provide a high level of protection to the health of patients and users.
For IVD market authorizations, it is necessary to validate the critical aspects of certain operations that take place starting with the research-development phase and ending with the production itself.
DDS Diagnostic has the expertise to provide support for the following activities during the development, manufacture and validation of IVD kits. - the performance evaluation plan; - technical report for analytical performance, e.g. analytical sensitivity, specificity, bias, accuracy (repeatability and reproducibility), accuracy, detection limits, measurement range measurement; - technical report for clinical performance, e.g. sensitivity and specificity of the diagnosis, positive predictive value, negative predictive value, probability rate, expected values in normal and affected populations; - Documentation regarding the risk management system; - stability and shelf life; - IVD labeling documentation and instructions for use; - Technical documentation: description and specifications of the device.
If you have a project about IVD kits, for more details and if you want to request an offer, do not hesitate to contact us.