The Medical Device Regulation (MDR) presents manufacturers, dealers, service and supply companies in medical technology with numerous new challenges: Companies must ensure the traceability of each individual product as well as seamless change control. In addition, the new regulation requires standard-compliant risk management and the validation of all software solutions used. Companies have to invest a lot of time and money in implementing all of these different requirements. But if you not only recognize the MDR as a necessary obligation, but also use the opportunity it offers to restructure processes, you ultimately benefit from more efficiency and transparency - and are also well positioned for future challenges such as digital transformation. For example, the introduction of UDI labeling makes an important contribution to digitalization in the warehouse.

In order to be able to meet these numerous requirements, medical technology manufacturers need an ERP system that guarantees seamless documentation and area-wide monitoring and enables cross-departmental collaboration. This is the only way to ensure product quality and data integrity and ensure patient safety.

Comprehensive quality management

A key component of the approval requirement for medical devices is a quality management system implemented in the company. This must meet the requirements of ISO 13485: 2016 and 21 CFR 820, as well as cover the entire process chain from incoming goods with supplier evaluation through production to logistics and service, as well as ensuring consistent compliance and traceability. Various tasks that standalone software can only perform to a limited extent inevitably lead to system breaks and thus to possible errors. An integrated ERP solution, on the other hand, offers comprehensive functions for quality management and networks all areas: from quality control in the incoming goods department to the QA workstation and outgoing goods. The data on the reject rate, errors and other product-dependent measurement data recorded during the quality controls are stored directly in the system and are available for later tracking and evaluation. Functions such as test equipment management and the reminder of calibration dates support quality management in daily work. In this way, the causes of errors occurring can be quickly determined and preventive measures can be taken to rule out possible sources of errors in the future.

Complete batch tracing

The possibility of being able to understand the creation of each product step by step ensures more transparency - and therefore security - and is therefore a cornerstone of MDR. Batch and serial number management integrated in the ERP system is necessary for this, which guarantees continuous traceability down to the individual product components. Incoming and outgoing batches are registered and enriched in the system with information such as supplier number, movement and storage information. In this way, the entire batch history is available at any time at the push of a button in the event of problems that arise after being placed on the market and, if necessary, a targeted recall campaign at component level can be initiated. Stocks with the exact specification of the best-before date and range assignments per customer are also available at any time.

Clear product labeling

The basis for seamless traceability is the unambiguous labeling of the products with their master data and product information. For this reason, the American health authority FDA introduced the UDI system (Unique Device Identification) in 2011, which ensures the uniform labeling of medical products worldwide. For this purpose, the UDI-DI code ("Device Identifier") with the most important product and manufacturer data and the UDI-PI ("Production Identifier") with the information about the respective batch are combined. In the future, this product identification number must be specified on all medical device packaging in accordance with MDR. For this purpose, the ERP software stores the UDI data for the article, prepares it and transfers it to a label program that takes over the layout and control of various printers - including consideration of the different types and sizes of labels. In addition, companies can optimize the processes in warehousing and logistics by using an ERP system in combination with the UDI. B. Serial and batch numbers are recorded and transferred directly to the ERP system. This procedure not only saves time, but also reduces the error rate because manual data entry is no longer necessary. And the entry of articles in the EUDAMED database can also be fully automated with the ERP system - thanks to the upload function.

Transparent complaint management

Good service contributes to higher customer satisfaction. This applies all the more to the handling of complaints and complaints in the medical technology area, in which the products sometimes take on vital tasks. However, not only can customer satisfaction be increased through transparent complaint management, but systematic product or process errors can also be prevented. Because the data collected over a longer period of time result in meaningful analyzes that can be used to improve product quality. The basis for this is a central administration of the reported complaints and complaints in the ERP system. An integrated workflow ensures that the processes initiated are processed in compliance with the law and standards and stored in an audit-proof manner. Events that must be reported are also documented here and can be used for later investigations. This is rounded off by integrated risk management (via FMEA) including an embedded CAPA administration.

Perfect support

Awarded as ERP system of the year in the field of medical technology Industry solution from KUMAVISION brings everything to perfectly support companies in complying with regulatory requirements and validation according to the Medical Device Regulation.

• Compliance-oriented processes (MPG, ElektroG, ISO, GMG, FDA, UDI etc.) as well as serial and batch number tracking at component level of the products.
• Four-eyes principle with workflows for approval and audit trails for seamless change tracking including support for 21 CFR Part 11
• Distinctive quality management through freely definable test plans and integrated test equipment management - including supplier evaluation
• Professional handling of service, repairs and complaints for more customer satisfaction
• Validation the production processes as well as the ERP software according to DIN EN: 13485
• Graded user authorization concept
• Risk and Complaint Management (FMEA)
• Integrated document management system (DMS)
• Electronic device file (Medical Device File)
• Mandatory field exams

In addition to the provision of validable ERP software for medical technology, KUMAVISION also offers comprehensive support for the validation itself: To do this, the ERP specialist works with partner companies that specialize in customers from the pharmaceutical industry and medical technology - both nationally and in Germany international environment.

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