ERP compliance – a requirement for regulated companies in the medical device industry

The medical device industry navigates between innovation and strict regulations. With MDR and FDA requirements for companies selling their products in the USA, along with ISO 13485, compliance demands are increasing, especially for SMEs. An ERP system that integrates these regulations makes complex processes efficient and transparent, forming the foundation for sustainable success. Our contribution clarifies the facts and presents solutions.

ERP systems have evolved far beyond their original roles in inventory management and financial accounting. In the medical device industry, they play a central role by integrating regulatory requirements directly into daily workflows, laying the foundation for sustainable business success.

A modern ERP system enables:

• Traceability across the entire supply chain—from batch management to unique device identification (UDI).
• Change management that ensures modifications and updates are recognized and securely documented.
• Integrated quality control with inspection plans, CAPA processes (corrective and preventive actions), and risk assessments.
• Audit assurance through comprehensive electronic records and electronic signatures.

Compliance thus becomes a natural part of value creation and an essential element of the entire process.

To ensure compliance, an ERP system must guarantee that the main requirements for the medical device industry are met:

• MDR (EU): Establishes, among other things, stricter requirements for technical documentation, traceability, and risk management.
• FDA (USA): 21 CFR Part 11 is particularly relevant, as it regulates the management of electronic records and signatures.
• ISO 13485: This is the international standard for quality management systems in the medical device industry and a key basis for many certifications.

Integration of these requirements into a central ERP system is especially beneficial for small and medium-sized enterprises. This holistic approach avoids redundant processes and leverages resources where they create the most value.

Whether by notified bodies, authorities or customers, external quality audits play an important role for companies in the medical device industry. Companies are required to transparently demonstrate at all times that their processes comply with current regulations.

A validated ERP system provides significant benefits in this context. Essentially, these include:

• Quick access to audit-relevant data (e.g., production steps, test results, documentation).
• Audit-proof archiving of data and documents.
• Process validation of the system itself to meet MDR and FDA requirements.

Not every ERP system is suitable for regulated industries. SMEs in the medical device sector should ensure their solution provides the following features:

• Validation capabilities according to regulatory standards
• Support for MDR, FDA, and ISO 13485 compliant processes
• Electronic signatures and audit trails
• Industry-specific features such as CAPA workflows and quality control
• Integration into the existing IT landscape, without isolated applications

ERP systems for regulated industries significantly relieve SMEs. Yaveon 365 demonstrates how this works: The solution is built on Microsoft Dynamics 365 Business Central and integrates industry-specific compliance features directly into the core processes.

The critical difference: Regulatory requirements are embedded from the start in every step of the workflow, rather than added on later. This provides companies with greater security during quality audits, streamlines their operations, and offers a solution that scales with their growth.

For medical device companies—especially small and medium-sized enterprises—ERP compliance is much more than just a regulatory obligation. The complex requirements of MDR, FDA, and ISO 13485 demand complete transparency and comprehensive traceability in every process step.

This challenge turns into a genuine opportunity: A specialized ERP system transforms compliance obligations into a real competitive advantage. End-to-end processes provide clarity, audit security instills confidence, and robust system architecture prepares you optimally for future demands.