If you manufacture medical devices, our ERP is part of your quality system, and auditors treat it that way. Every lot you receive, every serial number you build, every deviation you document and every label you print has to be traceable, controlled and defensible.
On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) took effect, rewriting 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. The FDA also retired its long-standing QSIT inspection approach in favor of a new inspection program aligned to the QMSR. For many mid-sized device makers, that change has exposed a problem: the spreadsheets, paper travelers and aging on-premise ERP systems that “got us through” the last audit aren’t a strategy for the next one.
Microsoft Dynamics 365 Business Central, extended with purpose-built life sciences solutions, offers a way forward.
Can Dynamics 365 Business Central support medical device manufacturing? Yes. Business Central provides manufacturing, inventory, financial and supply chain capabilities, including lot and serial number tracking. However, manufacturers operating under FDA QMSR and ISO 13485 requirements typically need additional quality management, electronic signature, audit trail and validation capabilities. That’s where industry-specific solutions such as Yaveon 365 come in.
Common ERP challenges for medical device manufacturers
Most growing device manufacturers we talk to share a familiar set of pain points:
- Traceability gaps. Lot and serial genealogy lives across ERP, spreadsheets and paper records, so a recall or complaint investigation becomes a multi-day scramble.
- Validation fatigue. Every system upgrade means re-validating, so teams delay updates for years and fall further behind.
- Disconnected quality processes. CAPAs, nonconformances, inspections and approvals happen outside the ERP, which means duplicate data entry and audit trails that don’t connect.
- Legacy platforms nearing end of life. Many manufacturers are still running Dynamics GP, older NAV versions or homegrown systems that weren’t designed for today’s regulatory expectations or for the cloud.
The goal is to make compliance part of how work gets done every day, rather than a fire drill before an inspection.
How Dynamics 365 Business Central supports medical device manufacturing
Business Central gives mid-market manufacturers an enterprise-grade platform without enterprise-level complexity:
- Native lot and serial tracking across purchasing, production, inventory and sales, with item tracing that shows where every component came from and where every finished device went.
- Integrated manufacturing including BOMs, routings, production orders and capacity planning in the same system as finance and supply chain.
- Cloud on Microsoft Azure, with Microsoft-managed infrastructure, security and continuous updates.
- The Microsoft ecosystem working together: Outlook, Teams, Excel, Power BI for quality and operational dashboards, Power Automate for workflows, and Copilot to help teams find answers and act faster.
- Room to grow, from a single plant to multi-entity, multi-site operations, without changing platforms.
On its own, Business Central is a strong general-purpose manufacturing ERP. For regulated device makers, extending it with ISV solutions built specifically for life sciences adds the specialized capabilities they need.
What medical device manufacturers need from a compliant ERP system
Independent Software Vendors (ISVs) build specialized applications on top of Business Central to meet the needs of specific industries. For medical device manufacturers, the right ISV solutions add the functionality regulators expect to see, while keeping everything inside one system and one data model.
Capabilities to look for include:
- Validation-ready design, so you can validate the system efficiently and keep it validated through updates.
- Complete audit trails that record who changed what, when, the original value and why.
- Electronic signatures that support FDA 21 CFR Part 11 requirements.
- Quality management workflows such as CAPA, inspections, quality control and release processes, built into core ERP transactions rather than sitting in a separate tool.
- Batch and serial genealogy with fast, auditable forward and backward tracing.
- Inventory controls such as FIFO/FEFO consumption and expiration management.
- Complementary solutions for areas like labeling, UDI data management, document control and EDI, depending on your products and customers.
With this approach, quality and compliance processes become part of the ERP your teams already use, reducing the need to manage them in separate systems.
BCS’ partnership with Yaveon
BCS partners with Yaveon, one of the leading Microsoft ISVs focused on regulated industries including medical devices, pharmaceuticals, biotech, chemicals and food.
Yaveon’s flagship solution, Yaveon 365, is an industry-specific ERP built directly on Dynamics 365 Business Central. Rather than bolting compliance on after the fact, it incorporates regulatory features into the core processes of the ERP. For medical device manufacturers, that includes:
- Developed according to GAMP 5, so Yaveon 365 can be validated as standard software, reducing your validation effort and supporting control over every system change.
- Support for MDR, ISO 13485 and FDA 21 CFR Part 11 requirements, from development through distribution.
- Comprehensive audit trails and electronic signatures built into the system.
- CAPA workflows and quality control integrated with production and inventory.
- Seamless tracing of batches, materials and serial numbers, quickly and auditably, when speed matters most.
- Batch inheritance and characteristic calculation, FIFO/FEFO consumption posting, and integration with QA.
- The Yaveon 365 Compliance Kit, which supports all phases of the validation process for Business Central and Yaveon 365, including supplier qualification of Yaveon and Microsoft.
Yaveon also releases updates shortly after each Microsoft Business Central update, so you stay current on the platform instead of getting stuck on an old version. Yaveon 365 was also named ERP of the Year 2025 in the process manufacturing category.
BCS brings the Business Central implementation, migration and integration expertise, while Yaveon brings deep life sciences functionality and validation know-how. Together, we can deliver a system that supports your operations and stands up to your auditors.
What this looks like in practice
Imagine a complaint comes in on a specific device. Instead of pulling paper travelers and cross-referencing spreadsheets, your quality team traces the serial number back through every component lot, supplier and production step in minutes. They can see who approved each step, open the related CAPA and document the investigation, all in the same system, with a full audit trail.
When that information is readily available, your team is better prepared for both day-to-day quality investigations and regulatory inspections.
Is it time to rethink your ERP?
If any of these sound familiar, it’s worth a conversation:
- You’re preparing for, or recovering from, your first QMSR-era FDA inspection.
- You’re running Dynamics GP, an older NAV version or a legacy system and planning your next move.
- Your quality processes live outside your ERP.
- Validation is the main reason you avoid upgrades.
- You’re expanding into new markets and need to meet both FDA and EU MDR expectations.
Let’s talk
BCS helps small and mid-sized manufacturers adopt Microsoft Dynamics 365 Business Central in a way that’s practical, cost-conscious and built to last. With our Yaveon partnership, we can help medical device manufacturers modernize their ERP and strengthen regulatory compliance at the same time.
Ready to see Business Central and Yaveon 365 in action for medical device manufacturing? Contact us to schedule a discovery conversation or demo.
Does Dynamics 365 Business Central meet FDA 21 CFR Part 11 requirements?
Business Central provides core ERP functionality, but manufacturers need to evaluate the complete configured solution against applicable Part 11 requirements. Yaveon 365 adds capabilities such as electronic signatures and audit trails that help organizations address those requirements. Validation and procedural controls remain the manufacturer’s responsibility.
Can medical device manufacturers migrate from Dynamics GP or NAV to Business Central?
Yes. Manufacturers running Dynamics GP or older versions of Dynamics NAV can migrate to Business Central. The migration should account for historical lot and serial records, quality documentation, existing integrations and validation requirements. BCS helps manufacturers plan and execute that transition.
