Ensure growth and compliance—let your medical device business expand with an ERP solution that meets today’s requirements and tomorrow’s challenges.
Book a consultation
The medical device industry operates in a highly regulated environment where compliance with standards like GMP, MDR, and FDA is critical. Challenges such as product development, secure data management, and system validation are part of daily operations for medical device companies. With Microsoft Dynamics 365 Business Central, you get a cloud-based ERP solution that streamlines operations, ensures regulatory compliance, and creates the foundation for innovation and growth in a rapidly evolving industry.
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.
Medical device companies in the U.S. must comply with regulations such as FDA 21 CFR Part 11, ISO 13485, and other FDA quality system requirements. These rules demand rigorous documentation, traceability, quality controls, and digital logs. Many companies struggle with manual processes and systems that aren’t built to support validation or a proper audit trail.
Medical device manufacturing is often batch-controlled, involving complex formulations, sensitive materials, and strict hygiene practices. Small errors can have major consequences. At the same time, full traceability in both directions—from raw materials to finished product—is required to ensure quality and safety.
Meeting regulatory requirements in the medical device industry demands far more than spreadsheets and disconnected systems. Traceability, quality management, and…
What capabilities should an ERP system include to properly support medical device manufacturing? For companies operating in process-driven environments, the…
Many ERP systems were never designed to support the regulatory demands of the medical device industry. Yet many organizations still…
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.
Choosing the right business solution isn’t always easy. Reach out to us, and we’ll guide you through the ERP landscape. That’s our area of expertise.
Contact