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Since September 2019, rantronik has been assisting a manufacturer of medical devices with obtaining qualifications for systems and validating processes under the Medical Device Regulation (MDR). 
Among other objectives, this project aims to commission two new systems which use laser welding technology to manufacture medical products, such as endoscopes and other instruments. 
As it is difficult to verify the subsequent process results, welding processes are generally classified as requiring mandatory validation. The basis of each manufacturing process to be validated constitutes the qualification of the production systems used.The qualification, which is carried out in successive stages, provides the documented evidence that a system has been designed, constructed and installed in accordance with the user requirements and the applicable regulations, and that it provides the required performance. 

By definition, validation is "documented evidence which provides a high degree of certainty that all of the processes, methods and systems which influence product quality consistently produce results that meet the acceptance criteria specified beforehand". 
Both the qualification of systems and the validation of processes constitute a component of good manufacturing practice (GMP) and are intended to ensure that products are of a consistently high quality standard. The requirements of the quality management system are continually rising, as can currently be seen in the new MDR, for example.
As an external partner company with industry expertise and experience, rantronik is therefore ready to provide assistance to ensure that all of the required steps are tested, implemented and documented.

In the current project, the design qualification (DQ) has already been completed. Once the laser welding systems have been installed, testing is undertaken for an installation qualification (IQ). 
During this step, checks are carried out to ensure that the required system documentation from the system supplier is available, among other requirements. The IQ also comprises checks that the system has been correctly installed (installation check, connections to infrastructure and the subsidiary equipment, media supply) and checking the installed automation system.
Checks are then undertaken in the operational qualification (OQ) to ensure that the system functions as specified. Testing by rantronik includes critical process steps, functions, alarms and locking systems, among other checks. 
In addition, checks are carried out to ensure that there are the necessary work procedures for operation, cleaning, maintenance and servicing, and that the employees have been trained.
According to the internal validation concept, the final performance qualification (PQ) is already a component of the process validation. Following the completion of the operational qualification, the qualification project proceeds to the relevant performance qualification, which is also currently planned, coordinated and implemented by rantronik.
In this sub-project, rantronik is responsible for the installation, operational and performance qualifications, as well as for the process validation. This means that the rantronik specialists are responsible for planning and documentation and are present with a "hands-on" mentality to help specialist staff ensure that the tests of the systems are carried out properly.
As the customer will be in the process of building their own in-house qualification team during the MDR, it is also the task of the rantronik consultants to teach, train and support a group of in-house employees.
Thanks to our many years of practical experience in the industry, we are very confident that with rantronik we will be able to successfully implement the project by 20th May.
Please do not hesitate to contact us if your company has any questions about qualification and validation related to MDR.

rantronik is very carefully monitoring the World Health Organization's guidelines and recommendations concerning the spread of coronavirus on a daily basis. This is because the safety and health of our customers' employees and our own colleagues is always our highest priority. 
We wish you well and good health!