MDR-compliant ERP solutions for medical technology

Medical technology is facing numerous challenges due to strict regulations and rising costs. In particular, the MDR (Medical Device Regulation)poses considerable challenges for companies. Although transition periods until the end of 2028 can be utilised, medium-sized medical technology companies in particular must take action.

Effects of the MDR on medical technology

Medical Device Regulation (MDR)

EU regulation on the regulation of medical devices, which replaces the previous directives.

Main features:

Increased requirements for clinical data and proof of safety
Introduction of a Unique Product Identification System (UDI)
Mandatory quality management systems for all risk classes
Stricter monitoring and reporting obligations for manufacturers
Re-evaluation and re-accreditation of all Notified Bodies

The MDR significantly raises the requirements for quality assurance and compliance. Companies now have to undergo clinical trials and certifications, which extends the authorisation processes. Stricter requirements for traceability and market access increase the pressure even further as a result.

A crucial point is regulatory compliance, which relates to systems that are significantly involved in the creation of products. This therefore refers to compliance with legal regulations, guidelines and standards that apply to a company. It is about fulfilling all relevant laws, rules and regulations imposed by regulatory authorities and supervisory bodies.

Rising costs and their causes

Medical technology companies are confronted with rising costs, which have various additional causes. On the one hand, rising energy and raw material prices are leading to higher expenditure. On the other hand, the strict requirements of the MDR are increasing costs considerably. The shortage of skilled labour and the high tax and duty pressure in Germany are further exacerbating the situation.

Low level of digitalisation and high need for action

At the same time, quite a few companies in the medical technology sector still use manual communication channels in quality management, which leads to isolated information flows and a lack of transparency. However, incomplete traceability can mean that companies do not fulfil the applicable regulations. Inefficient Quality management not only damages business, but also the company's image, especially if products have to be recalled.

In view of these challenges, there is a need for action in many companies. Investing in modern IT systems is therefore a crucial step towards meeting the requirements of the MDR and remaining competitive.

Why an integrated ERP solution is the answer

Integrated ERP systems offer a comprehensive solution for overcoming these challenges. They enable centralised management of all company processes, from production and warehousing to sales and financial management. A well-implemented ERP system can offer the following advantages:

Efficient data management:

With an ERP system, all relevant data can be stored and managed in one centralised location. This makes it much easier to comply with MDR requirements, as all documentation requirements can be met centrally and automatically.

VImproved production processes:

An ERP system helps to optimise production processes and use resources more efficiently. This is particularly important in an industry that is subject to high quality standards and has to work cost-effectively at the same time.

Transparency and traceability:

The traceability of medical devices is a key aspect of the MDR. ERP systems make it possible to track the entire life cycle of a product and also generate detailed reports that fulfil the legal requirements.

Choosing the right ERP system

Choosing the right ERP system is therefore crucial for the successful implementation of MDR requirements. SAP Business One is a popular choice for medium-sized companies in the medical technology sector. Not only does it offer extensive functions, it can also be flexibly customised to a company's specific needs.

The contribution of ERP systems to MDR compliance

ERP (Enterprise Resource Planning) systems offer an integrated solution to manage the complex requirements of MDR. Here are some of the key benefits:

Centralised data management

An ERP system enables all relevant data to be stored and managed centrally, making it easier to create and maintain the necessary documentation.

Automated processes

ERP systems can automate many of the administrative tasks associated with MDR compliance, such as creating audit trails and monitoring changes.

Validation of ERP systems for medical technology

This is particularly important in regulated sectors such as medical technology. Here, certain standards such as ISO 9001 and ISO 13485 which make proof of fault-free function and fulfilment of all requirements mandatory. Carrying out a Computer System Validation (CSV) is essential in this context. This validation proves that an ERP system reliably fulfils the intended tasks, i.e. does exactly what it is supposed to do.

Complete traceability

The integration of modules for supplier and customer management as well as supply chain management ensures end-to-end traceability from procurement to the end product.

Quality management

An ERP system also supports comprehensive quality management by monitoring and documenting all relevant processes from the procurement of raw materials to the completion of the product.

Conclusion

Compliance with the MDR is essential for companies in the medical technology sector. A suitable ERP system can help to manage the complex requirements while optimising processes along the entire value chain. Companies that rely on such systems are better equipped to ensure that their products meet the highest quality and safety standards.

SAP Business One ? Medical Technology

Specially developed ERP solution for small and medium-sized companies in the medical technology sector based on SAP Business One

SAP Business One Medical Technology is a customised ERP solution for medium-sized companies in the medical technology sector and related industries. This solution, which is based on the proven ERP system SAP Business One, offers a wide range of functions for the automation and optimisation of all business processes. These include purchasing, sales, customer relationship management (CRM), warehouse management, requirements planning, production, financial accounting and reporting.

The optional integration of applications and devices means that additional, external functions can be fully utilised. Thanks to the international orientation of SAP Business One, this solution is also ideal for globally active companies.

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