With a presence for over 15 years in the in vitro diagnostic industry, we have the capacity to offer support during the development, manufacturing and validation IVD kits. Also, we help our customers from the clinical labs to optimise their activity. Whether you need laboratory personnel training, assistance when obtaining erroneous results, documentation, laboratory performance assessment or actions to enhance the lab activity, we are able to help.
After purchasing our products, you can count on the technical support provided by the DDS Diagnostic Team, composed of skilled specialists. We constantly take part in professional development training courses to be able to provide you with technical and scientific support at the most competitive level, since we have a good understanding of your needs for promptly and professional services.
Specialised Training. Training in the use of in vitro diagnostics kits traded by DDS Diagnostic: The training is both theoretical and practical, giving you the chance to become familiar with the best lab practices as well as with electrophoresis methods, ELISA, CLIA or rapid tests.
The IVD kits and reagents are expected to be accurate, reliable and able to perform for the intended purpose. In many countries the national requirements sets high standards of quality and safety for in vitro diagnostic medical devices in order to offer a high level of protection of health for patients and users. For the IVD market authorizations is necessary the validation of critical aspects of particular operations.
DDS Diagnostic has the expertise to offer support for the following activities during the development, manufacturing and validation IVD kits.
Performance evaluation plan;
Technical report for the analytical performance, e.g. analytical sensitivity, specificity, bias, precision (repeatability and reproducibility), accuracy, limits of detection and quantitation, measuring range;
Technical report for the clinical performance, e.g. diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations;
Documentation regarding risk management system;
Stability and shelf-life
Documentation regarding IVD labeling and instructions for use;
Technical documentation: Device description and specification.
If you have a project regarding IVD kits, for further details and if you want to request a quotation, feel free to contact us.
You can order our products online
- 2.100,00 lei + TVA (19%)
- 575,00 lei + TVA (19%)
- 2.200,00 lei + TVA (19%)
- 600,00 lei + TVA (19%)
- 125,00 lei + TVA (19%)
- 500,00 lei + TVA (19%)
- 62,98 lei + TVA (19%)
- 52,50 lei + TVA (19%)