With the right software and the right partner

Wolfgang Renner

Heads the health market and medical technology division of KUMAVISION and is also responsible for quality management in this function.

The MDR changes the classification rules for medical devices. All computer-based systems that companies use for process control are also affected by this adjustment. These now belong to a higher risk class and must therefore be validated by a notified body. This regulation applies to all computer systems that are used in the course of the manufacture of a medical device in development, production, quality assurance, storage, repair or in trade. As a central system for company-wide process control, this also includes the ERP software. This means that medical technology manufacturers and dealers have to cover another area of ​​responsibility in the course of preparation for the new end of the transition period of MDR 2021. Fortunately, you are not alone, because ERP software providers such as KUMAVISION offer their customers comprehensive support, from a validatable system that covers all regulatory requirements to the creation of documentation.


How does the validation work?

It is not the software itself that is validated, but the way in which the software is used in the company. That is, whether the software specifications meet user needs and purpose. In other words, the validation process demonstrates and documents that the ERP system does exactly what it is supposed to do over its entire lifespan: namely companies with functions such as batch and serial number management, change tracking and graded user authorization concept while complying with national and international standards Support compliance requirements. It is therefore the responsibility of the company that the ERP software used complies with the applicable regulations.


What is being checked?

First, it is verified whether and how well the ERP system works in the respective area of ​​application. The software is qualified according to criteria such as usability, functionality and performance. A catalog of requirements is used to measure how well the ERP software is suitable for the intended use. The validation itself then focuses on the actual use of the software and how it is used in the specific process.

  • Comparison of specifications with the regulatory requirements
  • Risk assessment of the processes in terms of product and patient safety as well as data integrity
  • Appropriate tests and documentation


Worauf muss man esteem?

In order for the ERP software to be validated - it can be validated - it must offer functions with which companies can meet the regulatory requirements of MDR, ISO 13485: 2016, FDA and GMP. In addition to those already mentioned, this also includes, for example, an integrated supplier assessment, quality management, complaint management (e.g. via FMEA), an audit-proof document management system, an electronic device file, approval workflows and the UDI system (Unique Device Identification).

It is precisely this comprehensive support that KUMAVISION ERP offers for medical technology. Because the software solution, which was awarded the ERP system of the year in the medical technology sector, is based on many years of experience in a regulated environment and has exactly the functions that medical technology companies need. Manufacturers and dealers benefit from a powerful solution that offers the greatest possible future security.


Comprehensive support

In addition, KUMAVISION also supports companies in the creation and review of the necessary documentation and draws up an individual timetable with the necessary steps for successful validation. This procedure is essential because the validation requirements differ depending on the product and process. But with an experienced solution partner at your side who is very familiar with the validation requirements, the implementation succeeds.


Software validation with KUMAVISION

Find out more about how KUMAVISION supports you in validating your ERP system: To the validation packages

Find out more about how KUMAVISION supports VitalAire GmbH with workshops, best practice solutions and templates for validation: For reference


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