When audits, validation, and traceability live across spreadsheets, legacy systems, and disconnected tools, risk increases, teams lose time, and growth becomes harder to manage. Medical device companies do not operate in a “sometimes regulated” environment. They operate in a permanent audit-ready state. Compliance, quality, and validation are not side processes. They define daily operations. Yet many organizations are still running critical workflows on ERP systems never designed for regulated medical device environments. This is where a purpose-built Medical Devices ERP approach matters.
Contact us Check audit readinessRegulatory requirements evolve faster than legacy systems adapt.
Audit readiness depends on manual workarounds and tribal knowledge.
Validation activities consume disproportionate operational effort.
Batch and lot traceability is fragmented across systems.
Scaling production increases complexity instead of efficiency
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Explore a compliant ERP approach for Medical Devices
arrow_right_altMicrosoft Dynamics 365 Business Central provides a strong, modern ERP foundation but on its own, it was not designed to handle the full reality of Medical Devices regulations. Medical device organizations require more than core ERP functionality. They require:
check_circle Built-in audit trails
check_circle Electronic signatures
check_circle Computer system validation support
check_circle End-to-end batch and lot traceability
check_circle Quality management embedded directly into operations
A modern, cloud-based ERP foundation designed for scalability, security, and operational control.
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Medical Devices-specific industry solution that extends Business Central with compliance, validation, audit, and quality capabilities embedded by Yaveon.
Your implementation and advisory partner, responsible for translating regulated Medical Devices requirements into real-world ERP design, configuration, and long-term success.
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This approach provides:
check_circle Full audit trail across critical processes
check_circle Electronic signatures aligned with regulatory standards
check_circle Support for GAMP5 and computer system validation
check_circle Centralized quality and compliance data
This approach provides:
check_circle Batch and lot management embedded into daily workflows
check_circle Integrated manufacturing, warehouse, and inventory processes
check_circle Fewer manual steps and reduced operational errors
check_circle Clear visibility across production and distribution
This approach provides:
check_circle Reduced regulatory and audit risk
check_circle Lower long-term operational costs
check_circle Faster audits with fewer disruptions
check_circle A system that scales without increasing risk
The ERP system is designed to meet the strict regulations of the biotech industry, including support for audits and validation in a cloud environment.
By automating processes, you reduce errors and production time—boosting efficiency and freeing up resources.
Support for continuous quality control and easy access to all necessary documentation—fully digital and centralized.
Helps companies focus on innovation through centralized documentation, cost calculation for new products, and efficient recipe management.
The system provides full visibility over batches, improving transparency, traceability, and quick response to deviations.
With built-in AI and Microsoft Copilot, you get intelligent suggestions, automated workflows, and enhanced decision-making—directly within your ERP system.
Yaveon 365 Medical Technology is developed in close collaboration with medical device companies and is regularly reviewed through audits. Its modular design allows organizations to implement what they need now and expand as requirements evolve.
NAB Solutions ensures this technology is applied in a way that fits your business, your processes, and your regulatory obligations.
A validation-ready ERP system assists medical device companies in meeting regulatory requirements such as MDR, ISO 13485, and FDA 21…
GAMP5 can feel complex and regulatory heavy at first glance. But at its core, it’s a practical framework for ensuring…
Pharmaceutical and medical technology companies are required to validate their software to meet strict compliance standards. Computer systems must deliver…
At NAB Solutions, we’re more than a vendor — we’re a partner. That means we start with your business, not the product. We focus on understanding your needs, goals, and challenges to create solutions that actually solve them, rather than selling features you don’t need.
With extensive experience, proven methods, and hundreds of successful projects, we know what works in practice. And we stay with you all the way — from strategy and implementation to day‑to‑day use and continuous improvement.
The solution provides efficient production planning, optimized material requirements planning (MRP), digital batch records and electronic batch records (EBR), quality control, and automated workflows — all in a single system that also integrates finance, purchasing, and inventory.
With Business Central, you get built‑in support for traceability, batch management, and quality controls throughout the entire production process — from raw materials to finished products. Digital documentation, batch records, and clear audit trails create a structured foundation that makes it easier to meet regulatory requirements, work consistently, and demonstrate compliance during internal and external audits.
Whether you are preparing for audits, scaling production, or replacing legacy systems, the first step is understanding what “good” looks like for your organization.
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