With a new MDR module, the business software specialist KUMAVISION is supplementing its ERP industry software for medical technology with the handling of documents and approvals such as FDA, MDR and ISO 13485:2016 as part of the digital master file (Device Master Record/Medical Device File ) to demand. Whether production, purchasing, sales, distribution or service: the extension of the MDR module ensures that all required documents are automatically integrated into the respective business processes. This not only saves companies time and avoids double data maintenance, but also strengthens compliance, as it ensures that the current document version is always used. In addition, the MDR module monitors the validity period of approvals and supports the handling of articles that require approval.
The regulatory provisions are clear: companies must collect all the documents that describe how a medical product is manufactured, used and maintained in a kind of master file. This includes technical documentation, drawings, assembly and production instructions as well as specifications for testing or packaging, operating instructions, general terms and conditions, certificates from suppliers and declarations of conformity.
The MDR module ensures that these documents and information are integrated directly into the respective company processes ERP industry software from KUMAVISION for medical technology to get integrated. For example, a production order is automatically supplemented with assembly and production instructions including specifications for tool settings such as torque or device settings. When picking for shipping z. B. printed out according to the operating instructions, declaration of conformity, certificates and guarantee certificate. Audit-proof storage in the DMS and audit trail support ensure that regulatory requirements are met throughout the entire product lifecycle.
All approvals at a glance
Not all items may be sold in all countries. The MDR module manages country-specific approvals and checks when the offer is created whether an approval is stored in the ERP system for the target market. Similarly, the purchase of components can be restricted to selected dealers. In addition to MDR-specific tasks, the module can also be used to map exclusive contracts with a regional distributor or to limit delivery to certified sales partners.
Furthermore, the MDR module relieves medical technology companies in monitoring the validity period of approvals. With functions such as an automatic reminder before the approval expires, a status overview and assignment to employees, companies avoid an impending sales stop due to expired approvals.
From the MDD to the MDR
Products approved under the Medical Device Directive (MDD) enjoy grandfathering rights until their approval expires. The MDR module offers the convenient option of entering the information required by the MDR in the ERP system in advance. After the MDR approval, the article is automatically switched so that interruptions in the approval are consistently avoided.