Quality is our main value

Quality is a key element at Euro Diagnostica, codified in a quality system that has EN ISO 13485:2012 certification. Euro Diagnostica does not regard these standards as a maximum to be achieved, but as a basis for a further improvement of our expertise and know-how.

The advanced and extensive range of diagnostic products is the most tangible confirmation of our quality. Furthermore we ensure that our buyers receive excellent customer service and technical support. In this we combine our expertise with great commitment in solving the practical issues confronting our clients.

Euro Diagnostica ISO 13485 certificate BSI

Euro Diagnostica CMDCAS certificate BSI

QUALITY POLICY

Customer:

We meet our customers' needs and expectations by consistent dependability and by offering safe and effective assay solutions for use in in vitro diagnostics, monitoring and drug development. Our aim is to help medical experts to provide the correct treatment of patients in the areas of inflammation.   

Quality System:

The quality system assures that the products are fit for purpose. For IVD products the quality system meets regulatory requirements under EU Directive 98/79/EC (EU), SOR/98-282 (CA) and 21 CFR 820 (US) and the requirements of ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes. We continuously improve our systems and processes by regularly assessing our quality system, policies and objectives to ensure efficiency and reliability.

Products: 

Our products and services shall meet the requirements of customers and authorities with respect to design, performance and quality. We maintain consistently high quality of our products by quality assurance of the design, manufacturing and verification processes.

Personnel:

Each and every employee is responsible for quality. Quality is built into the products by trained personnel who takes Quality responsibility within every step, from early development to finish product.

Values: 

Our core values are dedication, responsibility and caring resulting in customer satisfaction.

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