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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.

strategic

priorities

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.

ISO 9001

ISO 13485

ISO 14001

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.

OEM manufacture

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.

CE

IVD

ISO

9001

ISO

13485

ISO

14001

ISO

International

Organization for

Standardization