DiagnoBlue Custom Solutions Department offers custom assay development services, conducted by our highly experienced R&D and manufacturing team which can be tailored to meet your needs such as bulk supply, private label manufacturing, and technical support.

Our team has been developing IVD products for decades and gained a reputation for achieving the highest performance levels in terms of sensitivity, reproducibility, accuracy, and specificity.

All the test development work is performed in accordance with the Medical Devices Directive (98/79/EC) is certified and marked with CE-IVD by MDC Medical Device Certification GmbH in Stuttgart/Germany together with the confirmation of Paul Ehrlich Institute (PEI) of Germany.

Our quality management system which is designed and effectively implemented in line with ISO 13485 covers all product realization processes.