How software solutions accelerate MDR compliance and reduce costs
The European Union’s Medical Device Regulation (MDR) places high demands on medical technology manufacturers. It requires extensive technical documentation, continuous updates and strict risk assessments. Software solutions such as BAYOOSOFT Themis enable companies to master these challenges efficiently. With digital and automated processes, the software optimizes MDR compliance and reduces costs at the same time.
Overview of the Medical Device Regulation (MDR)
The MDR, which has been in force since May 2021, has replaced the previous directives for medical devices and brings with it stricter requirements. The aim of the MDR is to ensure the safety and quality of medical devices in the European Union.
Important requirements of the MDR
Manufacturers must implement a variety of measures, including
The associated effort often leads to considerable burdens for companies, especially if the processes are carried out manually.
Efficiency through automation and standardization
The creation of technical documentation is a central component of MDR compliance. BAYOOSOFT Themis simplifies this process considerably. The software minimizes duplicate data storage and provides support in all phases of product approval. This ensures that all documents and data are consistent and manual processing is significantly reduced.
Central data management for maximum transparency
BAYOOSOFT Themis centralizes the management of documents and data. All relevant information is stored in a central, audit-proof location, which facilitates access and improves collaboration between teams. Changes can be tracked in an audit-proof manner and the standardized data structure ensures complete transparency. This is particularly important to ensure traceability and to be able to respond quickly to requests from authorities.
Integrated risk management in accordance with ISO 14971
The MDR requires a complete risk assessment that covers the entire life cycle of a product. BAYOOSOFT Themis integrates the requirements of ISO 14971 directly into the software and enables manufacturers to efficiently assess and document risks. The application supports the assignment of risk mitigation measures and links them directly to the corresponding technical documents. This seamless workflow not only ensures compliance, but also sustainably improves the quality and safety of products.
Advantages of BAYOOSOFT Themis in the context of MDR
The use of BAYOOSOFT Themis offers medical technology manufacturers numerous advantages:
- Efficiency increase
- Increased documentation quality
- Compliance security
- Time savings
- Cost reduction
Conclusion
The MDR presents medical technology manufacturers with considerable challenges. With BAYOOSOFT Themis, companies can not only meet these requirements, but also optimize their internal processes. Automation, digitalization and central data management help to reduce costs, save time and sustainably improve the quality of documentation.
BAYOOSOFT Themis is therefore an ideal solution for companies that want to work efficiently and future-proof.
