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Support throughout the qualification process

Would you like to use your laser systems to manufacture products in an environment subject to certification requirements? Our experts support you during the qualification process. 

Compliant installation and qualification of laser systems in regulated industries with TRUMPF expertise

It can be quite challenging to have your laser system certified in regulated industries. Not with TRUMPF qualification experts who provide you time- and cost-saving support throughout the qualification process and constantly continue to develop your range. Our focus is on the particularly comprehensive standards and requirements from the medical technology and aviation and aerospace sectors. This way, our services are oriented primarily toward the requirements of the following standards and institutions: ISO/ASTM 52941 / 52942, ISO 13485, ISO 9100, FDA, NADCAP, and more.

Standard-oriented installation

You can count on our comprehensive tests, measurements, and detailed documentation when it comes to preparing your system for certification. We carry out application tests for feasibility and find qualified parameters together to ensure the corrosion resistance to certain materials, among other things.

Reliable marking, welding and 3D printing

Within the framework of TRUMPF IQ/OQ services, we take all critical aspects of the installation and function of your machine into consideration in a standardized process. The stability of the laser processing procedure is additionally supported by the TRUMPF PQ/MQ service.

Efficiency in machine qualification and in operation

As well as the time-efficient machine qualification, we support you with optimum integration into your digital production environment, for example, inclusion in your ERP system. 

Long-term support

With our extended maintenance services you'll hold in-depth knowledge about the status of your system – every year.

Always playing it safe

Together with you, we will make sure that your system retains its certified condition, even after repairs.

We offer you the following services

Info graphic, equipment qualification IQ/OQ
Design Qualification (DQ)

We support you in the selection of the production technology which is best for you.

Contents

  • Advice on the process and material processing
  • Application tests for technology selection
  • Customer-specific specialized solutions

Your advantages

  • Foundation for successful equipment qualification
  • Suitable economic and technical solutions in accordance with individual requirements
Installation Qualification (IQ)

We check whether your system has been delivered and installed as ordered.

Contents

  • Review of the scope of delivery
  • Inspection of the machine installation, incl. hardware & software
  • Completeness of the documentation
  • IQ report

Your advantages

  • Time-efficient inspection of the scope of delivery and correct system installation by an expert
Operational Qualification (OQ)

We check your system for full functionality in accordance with the specified requirements.

Contents

  • System check & function checks
  • Inspection of safety functions
  • Verification of system specifications
  • Software functionality check
  • Application tests
  • Test report & OQ report

Your advantages

  • Safeguarding of the entire machine's specifications as defined in the DQ
  • Time-efficient documentation of the specifications by an expert
  • Ensuring the faultless operation of the machine for the start of the PQ
Performance Qualification (PQ)

We inspect your system for reliable and replicable production results.

Contents

  • Implementation of application tests to determine the process limits
  • Relaying of process expertise to staff

Your advantages

  • Obtainment of high quality and additional productivity by finely adjusting the parameters
  • Competently trained employees with outstanding product and process knowledge for permanently stable and efficient production processes
Maintenance Qualification (MQ)

We support smooth series operation of your system with maintenance and repair services.

Contents

  • Training courses on operation & maintenance of the system
  • Maintenance and service agreements
  • Remote services and 24/7 hotline
  • Support during application tests
  • System condition check 
  • Maintenance of machine qualification by checking and calibrating all process-relevant individual functions of the machine
  • Consistent and detailed documentation of all measurement results

Your advantages

  • High machine availability in production thanks to the services on offer and TRUMPF's worldwide presence
  • Lasting use of the machines within the established customer process thanks to long-term availability of spare parts
  • Competently trained employees ensure – with internally implemented maintenance – stable and productive production processes

Our customers say ...

"From the start of the certification process, TRUMPF enthusiastically supported us in finding solutions for the Nadcap question catalogue. The fact that zero errors were found during the audit, I believe, tells its own story about our successful partnership."

Christoph Hauck
Chief Technology and Sales Officer, toolcraft

We offer qualification support for the following systems*:

Metal 3D printing

after consultation:

  • TruPrint 1000
  • TruPrint 2000
  • TruPrint 3000
  • TruPrint 5000

The qualification support is primarily possible for all of our  TruPrint machines. However, to respond to individual requirements, it is always necessary to consult with the responsible experts at TRUMPF.

Laser marking
  • TruMark Station 5000 + TruMark 3230 and TruMark 3330
  • TruMark Station 5000 + TruMark 5020 and TruMark 5050
  • TruMark Station 5000 + TruMark 6030
  • TruMark Station 70001 + TruMicro Mark 2030​
  • TruMark Station 70001 + TruMark 3330​
  • TruMark Station 70001 + TruMark 5050​
  • TruMark Station 70001 + TruMark 6030

1only with TruMark Station lifting door

Laser welding
  • TruLaser Station 7000 + TruDisk
  • TruLaser Station 7000 + TruFiber
  • TruLaser Station 7000 + TruDiode
  • TruLaser Station 7000 + TruPulse

*The supported systems may vary depending on the country. Please contact us.

Find out more about our lasers

Laser marking systems

TRUMPF laser marking systems are available in different sizes and power classes for different component and lot sizes. They all have one thing in common: they can be easily and safely operated without additional protective measures – satisfying the most stringent ergonomic demands for standing as well as seated operating positions.

Photo collage of the LMD and LM processes
Additive production systems

Whether small, medium or large format machine – our additive production systems promise economic 3D printing in premium quality with simple and flexible handling. Find the most suitable laser 3D printer now for your industrial series production.

Laser welding with TRUMPF laser
Laser welding systems

If you are looking for a compact and cost-efficient 3D laser welding system, the TruLaser Station 7000 is the one for you. With this 3D laser welding system, you can process delicate or complex assemblies such as medical technological instruments with precision. You will be impressed by the high-quality, reproducible results without any need for post-processing.

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Black marking

Due to extremely short laser pulses, you can create durable and deep-black markings without damaging the material surface through ablation. The perfect procedure for creating corrosion-resistant markings, for example in the medical technology sector.

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UDI-compliant marking

In accordance with EU and US standards, medical products must be labeled with a uniquely traceable UDI code (UDI = Unique Device Identification). TRUMPF can offer you the perfect complete package comprised of marking laser and software for this.

Producing medical products with lasers

Whether it's orthopedics, plastic surgery, dental technology or the production of medical devices and instruments – with the help of lasers, you can produce medical products faster, better, and more efficiently. We'll show you how.

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