Service IQ, OQ, PQ, MQ:
Safe installation and qualification of
laser marking machines in medical device technology

Process validation is fundamental for the quality management in medical technology. An important role of the validation is the qualification of the manufacturing equipment. As a manufacturer of laser systems for marking medical devices, we work hand in hand with our customers with regards to this and provide extensive support in the installation and qualification of our laser marking machines.

Global standard for the process validation is FDA’s (Food and Drug Administration) “Current Good Manufacturing Practices” (CGMPs) guideline. For FDA compliant validation of the production process, following this guideline, our laser marking systems and machines pass through the required Equipment Qualification (EQ) in 4 steps (DQ, IQ, OQ, PQ/MQ). After the medical device manufacturer has finished the Design Qualification (DQ), decided for a laser marking system and prepared the specification sheet, we support the following qualification steps (IQ, OQ, PQ/MQ) for the laser marking machines delivered by us. Thus, we bring the know-how about the machines to the customer’s process in order to address a time efficient qualification, perfect adjustment and long-term process reliability. The IQ/OQ service is a proven standardized process addressing all critical aspects of the machine installation and functionality. The PQ/MQ service provides support for a stable, reliable marking process.

Installation Qualification IQ

By performing the Installation Qualification IQ, medical device manufacturers prove and document that equipment and machines are received and installed according to the requirements specified in the Design Qualification. This also includes checking if the working environment is appropriate. The Installation Qualification support for the delivered laser marking systems includes:

  • installation,
  • documentation, incl. spare parts
  • environmental verification requirements
  • safety checks

Operation Qualification OQ

The Operation Qualification (OQ) is related to the correct functioning of machines in the selected environment. The test evaluates that the equipment, including all customer-specific configurations, functions according to the specifications. The Operation Qualification support for the delivered laser marking systems includes:

  • complete system check
  • functional tests
  • calibration
  • marking tests
  • SW functionality incl. Access control

Performance Qualification PQ and Maintenance Qualification MQ

The Performance Qualification (PQ) verifies the equipment with regards to and as a part of the entire production process to prove and document that it is working reproducibly and consistently appropriate to its routine use within the specified performance parameters. The Maintenance Qualification refers to the machine operation, maintenance and service, including the service agreements. The PQ and MQ services include:

  • customized trainings
  • application tests
  • system check: recalibration and adjustment of configurations
  • continuous maintenance
  • service contracts


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