Microsoft Dynamics 365 Business Central for Medical Device & Life Sciences Manufacturers
Ensure compliance, strengthen traceability, and gain real-time operational visibility as production scales, all with an ERP solution built for regulated manufacturing environments.
Industry Challenges in Medical Device & Life Sciences Manufacturing
FDA Compliance & Audit Readiness
Maintaining audit-ready documentation and meeting FDA requirements is critical. Without integrated systems, compliance processes are fragmented, increasing the risk of non-conformance and costly regulatory penalties.
Lot & Serial Traceability
Tracking every component and finished product is essential for quality assurance, reporting, and recalls. Incomplete traceability can compromise patient safety and expose the business to liability.
Quality Management & Non-Conformance Tracking
Ensuring consistent product quality requires tight control over processes, materials, and deviations. Without real-time visibility, quality problems often aren’t noticed until it’s too late.
Production & Job Costing Visibility
Custom jobs, batch production, and regulatory reporting demands make accurate job and product costing challenging. Lack of insight into manufacturing, inventory, and financials can erode margins and hinder growth.
Operational Visibility Across Functions
Disconnected ERP, production, and inventory systems make it hard to monitor operations holistically. Limited visibility reduces efficiency, slows decision-making, and complicates regulatory reporting.
How Microsoft Dynamics 365 Business Central Supports Medical Device & Life Sciences Manufacturers
Lot & Serial Number Tracking
Track every component and finished product through production and distribution. Ensure recall readiness, maintain audit trails, and meet regulatory reporting requirements.
Quality Management & Non-Conformance Tracking
Monitor quality, manage non-conformance, and enforce standardized processes. Integrated controls reduce deviations and help teams stay ahead of compliance requirements.
Production Orders & Job Costing
Manage batch and custom production with accurate job costing, labor tracking, and materials usage. Gain insight into true product profitability while supporting regulatory reporting.
Secure & Role-Based Access
Protect sensitive operational and regulatory data with role-based security, permissions, and audit logging, ensuring compliance and operational control.
Advanced Reporting & Analytics
Leverage Power BI dashboards for real-time operational insights, compliance tracking, and executive decision-making across manufacturing, inventory, and financial processes.
eBook Download
How to Plan, Prepare and Succeed with your Business Central Migration
The decision to migrate to a new ERP system is not made lightly. At the end of the day, while commonly referred to as an “upgrade” or a “migration”, it is more than that. It is a complete reimplementation that often involves building a new solution from the ground up. Our eBook offers up advice on how to plan and prepare for a successful migration.
Proven ERP Leadership
Extensive experience delivering end-to-end Business Central solutions for highly regulated, audit-driven environments.
Regulatory & Compliance Expertise
Support for FDA compliance, lot and serial traceability, quality management, and documentation control.
Full Solution Delivery
We provide seamless implementation, integration, and ongoing optimization.
Operational Insights Across Functions
Integrated manufacturing, inventory, and financial reporting empowers proactive decision-making and process control.
More than an ERP, Custom Systems is a partner to medical device manufacturers, helping ensure compliance, visibility, and scalable growth.
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