A validation should check with objective means whether users can achieve the previously defined usage goals in a certain usage context. To put it in a nutshell: It is examined whether a product really does what the customer expects - does the product correspond to the intended purpose? In contrast to verification, the fulfillment of the requirements for the product is not checked, but how the product "works".

classical validation, usability validation, method validation and process validation

classical validation

Objective means are used to check whether (for example, from a technical point of view) the conditions are in place that the objective can be achieved.

Method validation as classic validation

This is the formal and documented proof that an analysis method is suitable for the specific purpose and fulfills the requirements. An important part of accreditations and approval procedures in the area of ​​drug approvals. Indispensable for procedures involving the higher federal authorities - e.g. BfArM (Federal Institute for Drugs and Medical Devices) and / or the American FDA.

Process validation as classic validation

Process validation is called process validation. ISO 13485 uses ISO 9000: 2015. The term process is broadly interpreted as "... a set of interrelated or mutually influencing activities, the input of which is used to achieve an intended result.".

Examples are: development, sterilization, production, hiring or sales process. Process validation is evidence that a process delivers the intended process results. ISO 13485 requires process validation if:

  • it is a production or service process and
  • Results of the process cannot be verified (measured) or
  • Process errors would only be noticed when the end product was used.


Usability validation could be translated as "usability test".

It should be determined whether the product is applicable and leads to the desired goal in the application. For this purpose, the applicability is checked with test persons within (e.g. a field trial) under defined special usage requirements.

An international standard IEC 62366 characterizes the conditions for a "usability validation". For projects with FDA approval, a look at the "Human Factors Engineering Guidance Document" from the FDA is recommended. It must therefore be specified:

  • The user group (representative)
  • The usage environment (context of use)
  • The actions to be taken to use
  • The usage goals

The usability process draws the manufacturer's attention (e.g. by simulating worst case scenarios) to risks that may arise during the intended application. These are then to be assessed in risk management.



We can provide support for our clients on the following points or organize, implement and document them for them:

  • Creation of a process validation master plan
  • Creation of validation plans for sub-processes
  • Development of the necessary documentation (IQ, DQ, PQ) including planning and report for the process validation of medical devices
  • Description of possible worst case scenarios based on your product.
  • Process validation for product changes
  • Assess and process complaints.
  • Validation of usability studies
  • Preparation of an FDA inspection or a QM audit by:
    • Method validations
    • Process validation
    • Verifications
    • Device qualification

for example for:

  • Manufacture of medical devices, u. a. in clean room (class 7)
  • Macros library (statistical programming))

Medical devices in the USA may only be sold if the safety and effectiveness of the product has been proven in a human factors study in accordance with FDA requirements. QiP GmbH can take care of the organization and preparation of this study or provide you with effective support. Our team of experts will be happy to help you.