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The ERP for the medical device

Yaveon 365 in Microsoft Business Central meets the highest standards while providing room for what truly matters: innovation that ensures security.

Comprehensive security: Documentation & traceability

Integrated compliance: Features for regulated processes

More time: faster development through automated processes

Red case containing packaged medical masks.Award for top ERP company in process manufacturing, 2025.
Over 850 companies worldwide rely on Yaveon
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How to achieve more with our ERP for medical devices.

Validated ERP system

Yaveon 365 is developed according to GAMP 5 and can be validated as standard software. This reduces your validation efforts and ensures security with every system change.

Ensure quality without additional effort

Integrated inspection processes, traceable workflows, and audit-proof documentation enable comprehensive quality management.

One-click traceability

In critical situations, speed is essential. With Yaveon 365, you can trace batches, materials, and serial numbers seamlessly—quickly, securely, and with full audit capability.

Regulations? Integrated.

MDR, ISO 13485, FDA 21 CFR Part 11: Our ERP system meets your industry's requirements from development to distribution—compliant and thoroughly documented.

Specific requirements in medical device manufacturing?
These ERP features will assist you.

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Manage deviations seamlessly

Respond systematically to deviations, complaints, and feedback to enhance product safety and reduce risk.

Permission sets & role center

Define incident types & error codes

Create incidents from documents

Implement standardized CAPA processes

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Reliably meet regulations

Safely and transparently meet regulatory requirements, including an audit trail and electronic signature.

User-specific permission sets

Electronic signatures according to FDA 21 CFR Part 11

Traceability via audit trail

Field security by user role

Audit trail entries screen with modifications and insertions.

Collect data on the go

Capture data accurately and in real-time for detailed traceability.

Warehouse receiving & transfer

Consumption & actual reporting in production

UDI & serial number collection

Order picking with packaging structure

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Inspection plan card for Yaviprofen bulk with quality control data.

Transparency in the warehouse

Manage your warehouse in compliance with GMP, including sensitive products and external partners.

FEFO Strategies & Temperature Zones

Warehouse receiving & pre shipment inspection, storage 

Map quarantine and inspection warehouses

Communication via EDI

Inventory list in Dynamics 365 Business Central interface.

Efficient production with results

Plan and document validated manufacturing processes comprehensively for secure outcomes.

Create manufacturing instructions

Batch inheritance & feature calculation

Consumption posting according to FIFO/FEFO 

Integration with QA and technology

Manufacturing specification screen for YAVIPROFEN bulk.
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Yaveon 365: the brochure for medical device companies

What else can our industry-specific ERP solution do for you? How does it simplify your tasks while ensuring secure operations? Discover all the critical information for success in the medical device industry in our brochure.
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It was also important to us that our ERP partner has a certain level of size . With many consultants in the background, resources are simply larger. This helps manage vacation times or illnesses.
— Michael Bachmann, Menicon GmbH
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Frequently asked questionsabout the medical device ERP solution

How does our ERP for medical devices support compliance requirements and validation?

Our ERP for medical devices meets the industry's high demands, including strict compliance with MDR and FDA regulations. GMP-compliant processes, audit trails, and lot tracking ensure transparent operations. Specific requirements such as comprehensive documentation are addressed and supported by our validation consulting. Modules like formulation and production scheduling optimize workflows and ensure compliance with legal requirements.

What are the benefits of implementing specialized software for medical devices?

Implementing a specialized ERP software for medical devices offers numerous benefits that cater to industry requirements. It ensures regulatory compliance and supports comprehensive documentation and traceability of production and quality control processes, which are crucial for audits and certifications. Additionally, the ERP solution optimizes production and resource planning through real-time data analysis, enabling efficient raw material use and preventing supply shortages. Transparency at every step of production minimizes errors and ensures product quality.

How does ERP software optimize medical device manufacturing?

An ERP software aids in the production of medical devices by streamlining production scheduling, resource allocation, and inventory management. It reduces bottlenecks, ensures compliance with regulatory requirements, and facilitates the automation of production processes. This not only enhances efficiency but also improves traceability and quality assurance, which are critical in the manufacturing of medical devices.

What costs are associated with implementing and maintaining ERP software for the medical device industry?

The cost of implementing and maintaining an ERP software depends on factors such as the size of your medical device company, the chosen solution, the need for customization, and the required features. The expenses include initial costs for implementation and ongoing costs for updates, support, and training.

Are there training materials available to assist employees in using the ERP system for medical devices?

In addition to our comprehensive online help, various training videos are available to make it as easy as possible for users to get started with the new medical device software.

Are updates and features provided to keep pace with the requirements of the medical device industry?

Together with Microsoft, we continuously deliver new updates to ensure our software remains cutting-edge and meets your exact requirements. Our goal is to provide solutions that not only adhere to current standards but are also forward-thinking and tailored to the specific needs of the medical device industry.

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