BERGER SURGICAL
About
Berger Surgical is a traditional company from the heart of the Tuttlinger Medical Valley. For more than 45 years, they have been working in the field of surgical services and are fulfilling the wishes of their customers, and their staff are outstandingly qualified and highly motivated to offer you the best possible service. The focus is on the production of surgical instruments for arthroscopy, orthopedics, laparoscopy, cardiology. Their know-how also covers the repair and custom-made surgical instruments as well as the production of prototypes and prototypes according to your specifications. Modern equipment for the production and a system for the validated final cleaning and passivation of the products are at our disposal. All processes and procedures in the company are certified according to DIN EN ISO 13485, so that we guarantee the highest quality of all products and services.
Why Choose BERGER SURGICAL?
Medical technology continues to evolve with every single day, new and innovative instruments dominate the market. New technology, however, always brings new legal requirements. Nowadays, a surgical instrument must not only defy several operations, but also have to stand up in the process of spreading. But a proper cleaning during the development and particularly before the first employment requires experience and know-how.
Because even this process entails a considerable effort in documentation and execution. New and existing standards in the QM area have forced a considerable amount of time to be spent in the final price. In order to meet this effort, there are only limited possibilities, you invest or you store it out and make a service out of it. We have made it our mission to offer exactly this performance.
UDI – unique device identification
Barcode for the marking of medical devices was previously a voluntary achievement of the manufacturers, now it becomes obligatory. The dates are set by the American Food and Drug Administration (FDA), nothing can be done without the accredited standards HIBC, GS1 and ISBT. Each of the standards has its features that make it possible to take advantage of it. The responsible persons for purchasing, materials management and IT can now refer to official guidelines, which are distributed worldwide and are reflected in central databases. This is a great advantage. The indication “UDI compliant” states that a medical device is clearly identified, other prescriptions are still valid
What does UDI mean?
UDI (Unique Device Identification) is more than one product code, UDI is a system. This is followed by the International Medical Device Regulatory Forum (IMDRF). Drivers are the US FDA, the European Commission, key players around the world, and affiliates such as the World Health Organization WHO. Legislators want to ensure that the traceability of medical devices is guaranteed at all times throughout the entire supply chain. This allows the authorities to initiate immediately necessary steps in the case of undesirable incidents and to recall products. UDI as a system includes both a unique code on the product or the packaging as well as the master data entries in a central database. The code requires an ISO-compliant, optical code carrier as an AIDC medium (bar code, 2D code).
Who wants UDI?
On 24 September 2013, the US authority FDA adopted the requirements for UDI. Accordingly, from 25 September 2014, UDI becomes compulsory for medical devices of the highest risk class. In Turkey, the requirement for “Unique Device Identifiers (UDI-DI)” and database entry has existed since 2008 for all medical devices. According to the activities of the ministries and parliaments, UDI is expected to be a worldwide requirement in the medium term. For manufacturers’ plans, the FDA’s legal requirement can be accepted as a general basis.