BluSense Diagnostics receives ISO 13485:2016 certification


In June 2017 BluSense Diagnostics achieved certification of its quality management system according to the latest EN ISO 13485:2016 standard. The certificate was issued by the notified body BSI, UK.

Implementing a quality management system is not only required by the European directive 98/79/EC to bring in vitro diagnostic devices to market, but also demonstrates BluSense commitment to develop and manufacture products which meet the highest international standards.

“Receiving this certification by BSI is an important milestone in the development of BluSense. During the past years we have focused on the development of IVD devices using our patented magnetic nanoparticles based detection technology. Our quality management system provides us the tools to meet the expectations of patients and customers by delivering high quality and safe products. We will now focus on bringing our products for the detection of mosquito transmitted diseases such as Dengue and Zika to market by the beginning of 2018” stated Robert Burger, COO of BluSense Diagnostics.  

Request for Proposal for Distribution of BluSense Diagnostics products

After a sustained period of development and following successful validation studies, BluSense Diagnostics (BSD) is seeking to engage service providers (Distributor) to provide local distribution services relating to its Viro-Track products (primary focus on Dengue NS1, IgG/IgM and COMBO products) in Asia and LATAM regions.

BluSense Diagnostics is inviting any qualified distributors able to provide these services, to submit their express of interest at the following email address: and include a comprehensive outline and references of similar distribution arrangements that the proponent firm currently has in place with organizations other than BluSense Diagnostics that are of similar size and magnitude.

In response to preliminary assessment, BluSense Diagnostics will engage in sending a full RFP for further evaluation and commercial discussion.

We would like to thank you for your time, effort, and interest in our vision to increase access to high-quality laboratory medicine to the population in needs.

Mr Fabrice GERARD –