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UDI Expert Talk: EU MDR UDI requirements – Strategies for addressing US and EU direct marking compliance
When:
Thursday, March 25, 2021
10:00 AM Eastern Time | 7:00 AM Pacific Time | 3:00 PM Central European Time
Your hosts:
Jay Crowley, VP of Medical Device Solutions and Services, USDM Life Sciences
Christian Söhner, Global Vertical Manager Medical, FOBA Laser Marking + Engraving
Summary:
UDI Expert Talk: EU MDR UDI requirements – Strategies for addressing US and EU direct marking compliance
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.
With the US Class I and EU MDR Class III direct marking compliance deadlines approaching, join us to learn about the differences in the requirements and strategies for compliance. USDM Life Sciences will address the requirements for US and EU MDR direct marking, FOBA will address how best to implement direct marking, and USDM will also provide QMS and validation guidance for direct marking.
This discussion with include:
- US Class I and EU MDR Class III direct marking compliance requirements
- Nuances and differences in the US and EU requirements
- Strategies to address the differences and simplify your UDI and validation efforts
- Implications to your Quality Management System (QMS)
After the presentation there will be a Q&A section.
UDI Expert Talk: How the safe UDI laser marking of my implant positively impacts its biological evaluation
When:
Thursday, December 10, 2020 / 10:00 - 11:00 AM US Central Time | 5:00 - 6:00 PM Central European Time
Your hosts:
Dr. rer. nat. Mohit Kumar, Project Associate, Medidee Services (Deutschland) GmbH
Christian Söhner, Global Vertical Manager Medical, FOBA Laser Marking + Engraving
Summary:
UDI Expert Talk: How laser marking the UDI on the medical device affects its biocompatibility
The biological safety assessment of medical devices is guided by the ISO 109993 family of standards, which provide a framework of chemical/physical/biological endpoints to demonstrate biocompatibility of the medical device. The laser markings on an implant can affect its biocompatibility, but proper processing and documentation can support the biological safety assessment of the device.
You will learn:
- When (and if) biological safety evaluation is required
- What impact laser marking can have on the biocompatibility of an implant
- What can be done to apply a laser mark safely
After the presentation there will be a Q&A section.
Virtual Manufacturing Day 2020: Series of lectures
We offer another exclusive access to the interesting exhibitor's lectures and to the panel discussion of Virtual Manufacturing Day 2020. Our webinar series provides presentations from the virtual event on November 24, 2020. This way we would like to offer all registered VMD-participants, and also other interested persons, to obtain further information.
We are looking forward to your participation!
Lasermarking of polymers and the improvement through laser pigments
When:
14. January 2021, 11:00 AM - 11:30 AM Central European Time (held in English)
Your host:
Silvia Rosenberger, Merck - Technical Marketing Manager
Topic:
- how we enable the materials to keep up with the speed of modern lasers
- why laser pigments are useful for marking of polymers
- which industries benefit from the use of laser marking
Design and Development and Speed to Market
When:
15. December 2020, 3:00 PM - 3:30 AM Central European Time (held in English)
Your host:
Ashish Shah, Viant Medical - VP Research Development & Engineering
Topic:
- Accelerated product development process
- Lean product development approach
- Lean product launch with high quality processes
(1/2) Lessons learned from the corona crisis
When:
December 3rd, 2020, 2:00 P.M. - 3:00 P.M. Central European Time (held in German)
Your hosts:
Niklas Kuczaty, VDMA Working Group Medical Technology - Managing Director
Summary:
- Efficiency of the German mechanical engineering in the field of protective equipment
- Political will to promote local production
- Networks are particularly important in times of crisis
(2/2) Expert talk: The medical technology of the future is networked – from the supplier to the medical professional
4 Perspectives:
- Christian Geppert, Viant Aura GmbH - Managing Director
- Niklas Kuczaty, VDMA Working Group Medical Technology - Managing Director
- Tanja Wendling, T4M Technology for Medical Devices - Project Leader
- Christian Söhner, FOBA Laser Marking + Engraving - Global Vertical Manager Medical
How to fix your pains with UDI-compliant
medical device marking
and save up to US$ 10,000 a year
When:
Wednesday, October 28, 2020
09:00 AM Central U.S. | 10:00 AM Eastern U.S. | 03:00 PM European Standard Time
Where:
Join FOBA's business manager Dr. Faycal Benayad-Cherif and Global Vertical Manager Medical Christian Söhner to learn how FOBA can help you improve your UDI laser marking!
Summary:
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?
Learn in this webinar:
- How a laser marking system with integrated vision can make fixtures completely redundant
- How FOBA's innovative vision inspection and mark alignment system "Mosaic" works
- What are the steps of a UDI-compliant marking process like FOBA's HELP (Holistic Enhanced Laser Process)-workflow
- How you can save tremendously when FOBA performs your IQ/OQ
SPE Plastics Decorating Magazine Webinar
"Smart Lasers in the World of Plastics"
by Dr. Faycal Benayad-Cherif
When:
Thursday, September 24, 2020 10:00 AM CT
Where:
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!
Summary:
Whether your industry is medical, automotive or aerospace, whether your job is anti-counterfeiting, traceability or decoration, laser marking technology has become an essential tool in the world of plastics. Among the factors that have contributed to this evolution are new performant, reliable, affordable and more intelligent lasers. The combination of laser marking technology and leading-edge imaging solutions such as Mosaic™ have opened the path to more innovative, attractive and higher quality products. The latest laser technologies have also enabled the miniaturization of human and machine-readable contents that allow full traceability while making parts difficult to counterfeit. How these technologies managed to address these challenges, success examples and the lessons learned will be shared during this presentation.
Acquisition of a laser marking system: Basics, questions, limitations and considerations
When
Thursday, September 10, 2020, 16-17:00 PM (CEST) | 10-11 AM (EDT) | 9-10 AM (CDT)
Your hosts:
Victoria Meß (Team Leader TLG Team) and Jeff Kniptash (Sales Engineer)
Summary:
HELP, I think I need a laser! - Leading the way to the purchase of a marking laser
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.
You'll learn
- which are the different types of marking systems
- which are the resulting marking effects
- how your marking requirements impact the choice of your laser system
- how to start a project step by step
- what is a reasonable pricing
- what best case examples are
AIM NA UDI Webinar Series
Direct Part Marking Using Lasers in the Medical, Automotive, & Aerospace Industry - How to Stay Compliant with DataMatrix, UID, and UDI Codes
When
Wednesday, August 26, 2020 11:00 AM EST
Where:
This Webinar is external via AIM North America
Summary:
Direct Part Marking Using Lasers in the Medical, Automotive, & Aerospace Industry - How to Stay Compliant with DataMatrix, UID, and UDI Codes
UDI Expert Talk: How to organize the compliant implementation of the MDR? What do I have to do by when? From gap assessment to postponed deadlines
When:
09. June 2020 / 10:00 o'clock (CDT) = 17:00 (CET)
The topic of our first UDI Talks is:
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
Your hosts Christian Söhner (FOBA Laser) and Michael Galliker (Regulatory Globe) will discuss:
- how companies can approach the implementation of the UDI according to the MDR (keyword "gap assessment")
- the relevant MDR regulations for direct part marking
- possible adjustments to the deadlines due to the latest MDR postponement
- the technical options for a UDI direct marking
Meet Titus™, the world's smallest laser marking head!
When:
May 7, 2020 / 10:00 AM (CDT) = 17:00 (CET)
This is what you will get:
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?
Then you should register to our webinar and meet Titus™, the smallest laser marking head in the world. Let Titus™ convince you with its size and innovative features that make laser marking so much easier for you.
See for yourself, ...
- how small Titus™ is compared to other marking laser systems
- how easy the setup is
- how easy the web-based operating system FOBA Go works
Fint out,...
- why Titus™ is so unique
- how simple setup and mounting works
- the amount of potential savings that Titus™ generates
Regulatory Update on UDI: What you need to know about UDI marking of medical devices, instruments and implants
When:
22. April 2020 / 10:00 o'clock (CDT) = 17:00 (CET)
This is what you will get:
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. The challenges for manufacturers and marketers are no less demanding. Although already in place for the US, the implementation of the MDR for the European market is often still unclear. Due to the Corona pandemic, the official start date for the EU has now been changed from 26 May 2020 to 2021.
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.
You'll learn:
- Why the UDI code is much more than a label and should not be underestimated
- What has to be considered for the technical implementation
- Things to know about readability and code size
- How to achieve process reliability during direct marking