We continue to build on the strong
momentum from last year to create
high-quality products and provide
excellent customer service.
Our mission is to create high-quality products and provide excellent services,
as well as introduce new or expanded production lines and sales ranges in
accordance with market dynamics and demands.
Product and service excellence makes BioGnost a desirable regional and
international business partner. The key to success is the ever-expanding network
of business collaborations, as well as recognizable social responsibility. In the
coming years we plan to further our market expansion, additionally invest in
research and development, and to become competitive manufacturer in the
fields of microbiological diagnostics and histopathology.
BioGnost’s entire business is in accordance with international ISO 9001, ISO
13485 and ISO 14001 standards. The company implemented ISO standards
more than 15 years ago, and it is the first Croatian company to implement the
ISO 13485 quality system for medical devices. Having fulfilled the requirements
of these standards, the company is completely in accordance with national legal
regulation and the European Union’s Medical Device Directive.
BioGnost’s products bear the CE mark, a certificate that confirms that the
products are in accordance with the European Union’s standards. They are
declared as in vitro diagnostic medical devices (IVD) classified as “Others”
(according to the Directive 98/79/EC). No control of the Notified Body is
required for this class; the company conducts compliance with valid regulations.
Besides products from our own sales ranges, we also offer OEM manufacture
for your company. It includes a wide range of services, such as label design,
product packaging, instructions for use and certificates of analysis, and products
manufactured according to your recipes.