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Customer Case Study Rudolf Medical

Customer Case Study Rudolf Medical

Customer Case Study Rudolf Medical

Product catalog summary
Introduction
RUDOLF Medical utilizes FOBA M-series fiber laser marking systems to mark medical instruments, meeting stringent UDI (Unique Device Identification) and MDR (Medical Device Regulation) requirements. The integration of camera-based laser marking solutions ensures serialized, permanently legible UDI codes, enhancing the marking process's reliability and efficiency.
Case Study Overview
RUDOLF Medical marks approximately 25,000 products annually, with over 90% already UDI-marked, complying with FDA and MDR regulations. The company, known for surgical scissors, has adopted laser marking as a technological success factor, replacing traditional chemical etching due to its corrosive nature.
Technological Advancements
The FOBA laser marking systems feature integrated cameras, enabling automatic component identification, marking alignment, and code read-back. This system offers reliable marking with Intelligent Mark Positioning (IMP) and Point & Shoot (P&S) for precise alignment, a three-stage marking process, and user-friendly software for parameter configuration.
Passivation Process
To ensure durability, RUDOLF Medical employs a passivation process for stainless steel instruments, following ASTM 967 standards. This process involves pre-cleaning, passivation, electropolishing, cleaning, and rinsing, ensuring the longevity of UDI codes even after extensive sterilization.
FOBA System Advantages
FOBA's short-pulse fiber lasers offer cost-effective, durable, and high-contrast markings. The systems are user-friendly, with intuitive software and comprehensive support, including FOBA Remote Service for proactive technical assistance, aligning with Industry 4.0 standards.
Conclusion
RUDOLF Medical's collaboration with FOBA has resulted in a complete UDI laser marking process, providing a competitive edge in the medical technology sector through advanced marking solutions and comprehensive support services.
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Catalog excerpts

Customer Case Study Rudolf Medical-1

Case Study: RUDOLF Medical Lasers as the standard of the future for the marking of surgical scissors and instruments Ideal for UDI and MDR requirements, thanks to camera-based laser marking solutions and comprehensive services. With FOBA lasers, RUDOLF Medical marks some 25,000 different products per year RUDOLF Medical marks medical instruments with FOBA Mseries fiber laser marking systems. This is done with conviction, as the marking lasers with integrated imaging meet the tough requirements of medical device marking. Important factors are the serialized marking of permanently legible UDI codes and an economic, slim, and reliable marking process, based on a laserintegrated camera control system.

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Customer Case Study Rudolf Medical-2

Specialist for surgical scissors – and way ahead when it comes to UDI Over 90 percent of all RUDOLF products are already directly marked with a UDI code (Unique Device Identification). This family company, renowned in particular for its scissors, is in full compliance with FDA (Food and Drug Administration) and MDR (Medical Device Regulation) statutory requirement. Products sold under the proprietary brand and those brought onto the market as part of OEM business through distributors are given logos, serial numbers, or UDI codes. “Even before the full enforcement of the actual marking regulations,...

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Customer Case Study Rudolf Medical-3

Case Study: RUDOLF Medical Universal marking lasers for medical technology Integrated imaging for more efficiency The camera integrated in the marking head enables a complete marking and read-back process in the enclosed laser marking machine. FOBA has quickly impressed RUDOLF Medical with this concept of automatic component identification, marking alignment, and code read-back. When facing the UDI regulations and searching for the most suitable technology, RUDOLF Medical's decision to work with FOBA was straightforward. According to Gerhard Faßbinder, it was clear as early as after the first...

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Customer Case Study Rudolf Medical-4

Firmly established with a clear advantage over ultrashort-pulse laser system Advantages of the short-pulse fiber lasers from FOBA: → A laser process developed over decades with integrated camera, integrated lighting, and automated marking alignment guarantees a stable and secure marking process. → Much lower procurement and beam source replacement costs than ultrashort-pulse laser marking systems. → Demonstrable durability of markings in long-term testing. → Sharp-precision, high-contrast markings that are only produced to this standard by short-pulse lasers enable optimum legibility, even for...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.