Certifications and Partners

GS1 Germany Solution Partner

GS1 provides standards for identifying, capturing, and sharing information.

Depending on the requirements and the data complexity, GS1 barcodes, e.g. GS1-128, GS1 DataBar, GS1 DataMatrix and GS1 QR codes according to GS1 standard are used for unique identification, data communication and traceability across industries worldwide, also for marking medical devices compliant to UDI. With the serialized Global Trade Item Number (sGTIN), which can be encoded in a GS1 barcode or an EPC/RFID tag, GS 1 standards help manufacturers to protect products against counterfeiting. As “GS1 Germany Solution Partner”, FOBA provides laser marking systems capable of marking parts and products according to GS1 standards and requirements.

GS1 Germany


HIBC Approved Solution Provider

The Health Industry Barcode (HIBC) is a global identification standard.

HIBC is used for unique identification and reliable traceability of medical devices and providing UDI-compliant product identification. The code is also applied in other areas for unique part marking. HIBC identifies parts and products uniquely through direct part marking with laser. The quality of HIBC integration is related to the marking quality. As „HIBC Approved Solution Provider“, FOBA provides HIBC conforming laser marking solutions.

www.hibc.de


ISO 9001

DIN EN ISO 9001 defines an international standard of quality management./p>

The ISO 9001 certification establishes the requirements for a quality management system regarding customer’s needs, product and service quality. As certified manufacturer, we meet and implement the requirements for a modern quality management system in order to achieve highest customers’ and employees’ satisfaction.

ISO 9001 Zertifikat


AEO C Certificate for Alltec GmbH/FOBA

AEO Certificate confirms reliability of customs operations for cross-boarder trade.

Since May 2016 Alltec GmbH is certified AEO C (Authorised Economic Operator, C-status) by the German custom authorities. This certificate is intended to facilitate and validate customs operations. It confirms that ALLTEC/FOBA Laser Marking + Engraving is a reliable company for international cross-boarder trade and the exchange of goods.

AEO certified companies are approved to be part of a safe supply chain from manufacturer to customer. They are authorized for facilitated customs handling.

AEO C-Certifikat


Medical Mountains

MedicalMountains GmbH connects and supports all players in the medical technology industry.

The organisation, headquartered in Tuttlingen, Germany, promotes dialogue, combines strengths and creates platforms for exchange. Cooperation and synergies are made possible through strategic and systematic coordination: Cooperation and mutual benefit with regional, national and international partners provide small and medium-sized enterprises in particular with an important knowledge and technology advantage.

Medical Mountains GmbH


Technology Mountains

German Technology Network - TechnologyMountains e.V. is a purely economic funded technology network and financed with annual membership fees.

Crossing traditional boundaries, TechnologyMountains provides access to expertise in precision engineering, automotive, electrical engineering, mechanical engineering and medical technology. TechnologyMountains sees itself as a link between business and science – building bridges and fostering collaboration in cross-disciplinary development projects. This way the technological leadership position of its members is secured and developed.

Quelle: https://technologymountains.de/

Being a member of Medical Mountains and Technology Mountains helps FOBA to maintain close contact with medical device manufacturers at the important Tuttlingen site and worldwide. Knowing their marking requirements is an important impulse for the continuous further development of innovative solutions for the UDI marking of medical devices.

Technology Mountains


Regulatory Globe GmbH

Regulatory Globe GmbH provides digital tools like the MDR Gap-Assessment toolor IVDR Gap-Assessment tool which helps companies to implement these new regulations in a simple way. Additionally, they provide «Access to Regulatory Affairs knowledge», which is required for all companies according to the new regulations MDR EU2017/745 and IVDR EU2017/746. And together with their partners, you get access to Regulatory and Quality Know-How, UDI marking experts, and EU-Authorized Representatives.

www.regulatoryglobe.com

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