Overview
Transforming Medical Device Production with D365 F&O
Microsoft D365 Finance and Operations (D365 F&O) is an impactful cloud or hybrid-based Microsoft ERP solution that enables businesses to manage their finances and operations with ease and efficiency. In the ever-evolving manufacturing landscape, staying ahead of the competition requires agility, efficiency, and innovation. As a trusted Microsoft partner, we specialize in delivering comprehensive solutions powered by Dynamics 365 Finance & Operations (D365 F&O) to help manufacturers streamline their operations, enhance productivity, and drive growth.
Medical device manufacturers and distributors operate under strict regulatory frameworks while innovating rapidly. UDI data integrity, device history record (DHR) completeness, complaint handling, and field service coordination are mission-critical. D365 F&O provides serialized traceability, integrated quality and CAPA, engineering change management, and global financial control within one platform. AXSource implements D365 F&O with UDI-ready data models, quality workflows, and service parts planning that align design-to-manufacture-to-service processes for faster, safer growth.
Core Medical Device Capabilities
6 Reasons Why D365 F&O is the Best ERP for Medical Devices
- UDI Data Management and Serialized Traceability
- Integrated Quality, DHR, and CAPA
- Design-to-Manufacture Alignment with Engineering Change
- Field Service and Spare Parts Planning
- Supplier Quality and Audits
- Global Financial Control and Scalability
UDI Data Management and Serialized Traceability
Microsoft Dynamics 365 Finance and Operations (D365 F&O) maintains accurate UDI attributes, serialize at item-pack levels, and track genealogy across manufacturing and distribution. This ensures compliant labeling, inventory control, and recall readiness.
Integrate Quality, DHR, and CAPA
Capture inspection results, deviations, and non-conformances linked to lots and serials. Structured CAPA workflows drive root-cause analysis and corrective actions. DHR completeness is supported by electronic records.
Design-to-Manufacture Alignment with Engineering Change
Synchronize engineering change orders with BOMs and production routings. Control effectivity dates and component substitutions. This minimizes rework and supports regulatory documentation
Field Service and Spare Parts Planning
Coordinate service schedules, warranty claims, and parts availability. Align service contracts with inventory planning to keep devices operational and compliant.
Supplier Quality and Audits
Score suppliers on quality, delivery, and compliance. Manage incoming inspections and approvals. Visibility into supplier performance reduces defects and risk.
Global Financial Control and Scalability
Consolidate multi-entity operations, standardize cost accounting, and manage intercompany flows. Scale to new regions and product lines with consistent controls and reporting.
General FAQs for Microsoft D365 Finance and Operations (D365 F&O) in Medical Devices Manufacturing
1. How does D365 F&O manage UDI data for medical devices?
Microsoft Dynamics 365 Finance & Operations (D365 F&O) maintains structured fields for UDI attributes and links them to items and labels. Serialization ties UDI to individual units for traceability. This ensures accurate labeling and supports regulatory submissions and audits.
2. Can D365 F&O maintain complete Device History Records (DHR)?
Yes—manufacturing records, inspections, deviations, and approvals are captured electronically. Batch and serial histories create complete DHRs for each device unit. This accelerates investigations and audit preparations.
3. How are CAPA workflows implemented in D365 F&O?
Non-conformances and complaints trigger CAPA with root-cause, action plans, and effectiveness checks. Workflows ensure timely resolution and documentation. Analytics highlight recurring issues and preventive opportunities.
4. Does D365 F&O support engineering change with effectivity control?
Engineering changes can update BOMs, routings, and specifications with effectivity dates. This controls when new configurations become active and prevents mixed builds. It reduces rework and ensures compliant documentation.
5. How does D365 F&O coordinate field service and parts availability?
Service contracts and schedules integrate with inventory planning and reservations. Parts lists and kits are aligned to common service tasks to minimize downtime. Warranty claims and returns feed back into quality analytics.
6. What supplier quality capabilities exist in D365 F&O?
You can score suppliers, record audits, and enforce incoming inspections. Vendor performance is visible across defect rates, delivery reliability, and compliance. These insights drive continuous improvement and sourcing decisions.
7. How does D365 F&O support global medical device operations?
Multi-company, multi-currency, and tax localization features enable global scale. Standard controls and reporting provide governance across regions. This architecture supports compliant growth.
8. Can D365 F&O integrate with PLM or QMS systems?
Yes—integrations synchronize engineering data and quality events. This maintains a single source of truth from design through manufacturing and service. It reduces manual reconciliation and errors.
9. How does D365 F&O help with complaint handling and post-market surveillance?
Complaints are recorded against serials, with workflows for investigation and CAPA. Analytics reveal trends and risk areas for targeted improvements. This supports regulatory expectations for post-market vigilance.
10. What does a medical device ERP implementation look like?
AXSource conducts discovery with quality, manufacturing, and service teams, then configures UDI, DHR, and CAPA workflows. We align engineering change and service parts planning, validate processes, and train users. Phased rollout ensures compliance and adoption.
11. What kind of reporting and analytics does D365 F&O offer for manufacturing?
D365 F&O provides robust reporting and analytics capabilities, including real-time dashboards, financial reporting, and predictive analytics. These tools help manufacturers make data-driven decisions and improve operational performance.
12. How does Dynamics 365 support budgeting and forecasting?
Dynamics 365 Finance and Operations offers robust tools to support budgeting and forecasting, enabling organizations to plan for the future and make informed decisions. Few of the Benefits of Budgeting and Forecasting in Dynamics 365 are
– Improved Financial Control: Gain better visibility into financial performance and identify potential issues early on.
– Enhanced Decision Making: Support strategic planning and resource allocation based on accurate forecasts.
– Increased Efficiency: Automate budgeting and forecasting processes to save time and reduce errors.
– Improved Collaboration: Facilitate collaboration among departments and stakeholders.
– Compliance: Ensure compliance with financial regulations and reporting requirements.
13. How can Dynamics 365 help with financial closing?
Dynamics 365 streamlines the financial closing process through automation, reconciliation, and reporting tools.
14. Can D365 F&O be accessed on mobile devices for manufacturing operations?
Yes, D365 F&O is accessible on mobile devices, allowing manufacturing professionals to manage operations and access critical information from anywhere, enhancing flexibility and responsiveness.
15. How can I configure audit policies in Dynamics 365?
You can configure audit policies to specify which data and actions should be audited. This helps balance security needs with performance impact.
