Today's healthcare is a very demanding and fast-paced environment. To keep up with these demands, healthcare professionals must be able to rely on state-of-the-art equipment to document every patient treatment while meeting any requirements set by the government or insurance companies.
Such state-of-the-art equipment is not always easy to find in a market where competition has caused prices to fall below expected demand, which then leads to a reduction in the number of providers.
To meet these customer and billing requirements, it makes sense to manage all relevant data in an ERP system.
This ERP system must meet the requirements of GAMP 5 for the validation of computer systems and fulfil the requirements of the MDR and FDA for medical devices and IVDs.
In order to carry out the necessary registrations, all relevant master data must be available in the ERP system. In addition, a complete quality management including CAPA is required.
Further requirements for ERP software in medical technology & home care:
Advising on the selection of an Enterprise Resource Planning (ERP) system is not easy. It requires specialised knowledge and a deep understanding to be effective as a consultant in this market segment, where companies need to increase their competitiveness by increasing efficiency or reducing costs, depending on which they choose.
With our expertise of medical device/UDI ERP software requirements, we are already defining the requirements of the new EU Medical Devices Regulation (EUDAMED database).
This will be introduced together with UDI in Europe, which is already used in the US. It is therefore important to include these specific requirements in an ERP specification as well.
In addition to the complete support of all business processes, compliance with regulations (e.g. DIN EN ISO 13485, MDR, 21CFR820) and the globally unique labelling of medical devices with UDI, integration into existing system landscapes is also possible.
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If you have any questions about digitisation or are looking for an ERP system for a medical technology or home care company, please use our advanced pages with this link or contact us briefly by mail. We'll be happy to help answer your questions and find the right solution for your business."
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