Biosigma: Biotechnology and Clinical Chemistry products

Company profile

facciata Biosigma

Since 1988 Biosigma S.p.A. produces and distributes disposable plastic items for biotechnology, research, clinical chemistry and pharmaceutical laboratories.

In our over 12.000 sqm facilities, we dispose of latest injection machines and informatics tools that allow production of high standard quality articles still being competitive on the worldwide market.

Every customer can count on a perfectly organized structure, ISO 13485, UNI ISO 14001 and UNI ISO 45001 certified, able to adapt our biotecnology products and services to continuous demands of market. We offer our customers experience and professional competence; customer satisfaction and quality of products are always our main targets.

Our efforts in research and development allow us to offer a growing and more advanced range of products both in Clinical Chemistry and Biotechnlogy fields.

Biosigma's manufacturing are CE marked in accordance with 98/79/EC directive related to In Vitro Diagnostic Medical Devices.

Since August 2011 Biosigma became part of Dominique Dutscher Group, leader in the distribution of consumables and equipments for life science and biotechnology market. Over 40.000-product catalogue and more than 140 brands like as Eppendorf, Thermo, Gilson, Nalgene Nunc. Pls. visit www.dutscher.com

Adherent to:

Member of:

Corporate Ethical Code

Certifications

Biosigma is always focused to the safety and the quality of his work reaching the most important certifications

ISO13485

ACT certification Environmental Impact Factor Label awarded by an independent auditor and published by My Green Lab® https://act.mygreenlab.org/ The ACT (Accountability, Consistency, and Transparency) label provides clear, accurate, fair, and greenwash-free information on environmental impact in all areas, including manufacturing, energy and water use, packaging, and end-of-life.

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ISO13485

ISCC certification is a voluntary scheme that is applicable for the bioeconomy and circular economy for food, feed, chemicals, plastics, packaging, textiles and renewable feedstock derived from a process using renewable energy sources. ISCC PLUS covers the same certification requirements as ISCC EU but can be customised to meet the needs of different markets or specific applications. All kinds of biomass, waste and residues, non-biological renewables and recycled carbon materials can be certified under ISCC PLUS.

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ISO13485

ISO 13485:2016 Quality System Certificate demonstrates and promotes the company’s commitment to organizational policies aimed at providing products and services in line with regulatory and market requirements related to the medical field.

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ISO14001

ISO 14001 is a tool that will allow the organization to manage the environmental impacts of its activities in accordance with the applicable law, continuous improvement, from a pro-active attitude towards environmental issues.

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ISO18001

The certification of the management system of health and safety in the workplace UNI ISO 45001:2018 is intended to provide security and tranquility that problems regarding the safety and health related to production processes are managed in a controlled way and that benefits in terms of safety are always monitored starting from the respect of conformity to mandatory legislation.

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fda

Registration Number: 3002945499
The production establishment and IVD Biosigma devices are registered with the FDA.


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