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 standardised 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 specialised 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 Service 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

To the success story

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.

To the product

Photo collage of laser metal deposition 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.

To the product

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.

To the product

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Black marking

Thanks 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.

UDI-compliant marking

In accordance with EU and US standards, medical products must be labelled 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 orthopaedics, 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.

Service & contact

Contact

TRUMPF Ltd.

Telephone +44 1582 725335

Fax +44 1582 399260

Downloads

Flyer - Qualification support IQ/OQ

pdf - 179 KB