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We bring you up to date on the current status of UDI direct marking of medical devices and give an overview of the UDI system according to MDR and FDA.
With the UDI system (Unique Device Identification) manufacturers are obliged to identify and register medical devices. UDI codes have to be reliably machine-readable to guarantee full traceability throughout the entire product lifecycle. As the requirements for direct part marking became more demanding, Centex Machining by Fathom, Texas, searched for a solution to their marking and productivity challenges. Especially for the marking of cylindrical devices like bone twist drills they found a solution that increased productivity and streamlined their processes.
In this educational Webinar Dr. Faycal Benayad-Cherif, will illustrate how the integration of inspection tools and automation in laser marking machines enables lean manufacturing processes. Use cases from the automotive and the medical industries will be presented.
FOBA invites you to an educational webinar on how to make automated laser marking processes simple, safe and economical. During this webinar, Faycal Benayad-Cherif, Global Strategic Account Manager at FOBA, will share the technical challenges and pitfalls to avoid when transitioning to automated laser marking.
With the UDI system (Unique Device Identification) manufacturers are obliged to identify and register medical devices. In the EU, the UDI is regulated within the framework of the MDR (Medical Device Regulation). In the USA, the FDA is authoritative. Seamless product tracking, less product piracy and highest patient safety are the goals. We bring you up to date on the current status of UDI direct marking of medical devices and give an overview of the UDI system according to MDR and FDA.
During this webinar, Faycal Benayad-Cherif, Global Strategic Account Manager at FOBA, will share the technical challenges and pitfalls to avoid when transitioning to automated laser marking medical devices. From cobots to fully automated solutions, from bone screw marking to cannula banding and drill bit marking, expect inspiration that will excite you need for automation.
Laser marking on metals like titanium or stainless steel can cause corrosion in the lasered areas. But only if corrosion is prevented, the direct mark on a medical device will remain durable throughout its lifetime. In addition, particle emission can only be prevented if the surface is intact, so that biocompatibility can be guaranteed, e.g. of an implant.
When it comes to reducing waste and increasing productivity while maintaining the highest precision and process reliability, camera systems are indispensable in laser marking machines. To ensure these conditions, we would like to introduce our three software solutions "Mosaic", "IMP" and "Point and Shoot". These solutions not only prevent the laser from marking the wrong part but also inspect the laser mark right after marking. Furthermore, our patented software feature MOSAIC allows you to easily label your product without expensive and time-consuming product fixtures.
In addition to labeling and packaging requirements, the US Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) regulation and the European Union’s (EU's) new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require certain devices to have UDI direct marking.
Virtual Manufacturing Day - Lectures Series
Accelerated product development process, Lean product development approach, Lean product launch with high quality processes
Equipment validation and process documentation are time consuming and delay a quick start of production. This also applies to the commonly required part fixtures used in the laser marking procedure. What if you could not only save fixture set-up costs but also documentation and qualification efforts?
This Webinar is external via SPE/Plastics Decorating Magazine. Join FOBA's business manager Dr. Faycal Benayad-Cherif to learn all about laser marking on plastic.
Numerous questions occur when projecting the purchase of a laser marking system. In our webinar "Help, I think I need a laser!" we discuss the main topics in this context.
Direct Part Marking Using Lasers in the Medical, Automotive, & Aerospace Industry - How to Stay Compliant with DataMatrix, UID, and UDI Codes
UDI and MDR: What do I have to implement by when? How do I organize the implementation according to the regulations? From gap assessment to the current postponement of the MDR transition deadlines
You need a marking laser for line integration, but you have almost no space available? You want a maximum of flexibility for integration and easy operation with an uncompromizing marking quality and marking speed?
With the UDI system (Unique Device Identification) manufacturers are obliged to identify and register medical devices. In the EU, the UDI is regulated within the framework of the MDR (Medical Device Regulation).
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