ERP for the medical technology

Q: Why is an industry-specific ERP solution important for my medical technology company?

An ERP industry solution helps medical technology companies meet the specific challenges of the industry. These typically include compliance with GMP, UDI, MDR, and FDA regulations, as well as a validation-ready ERP industry solution.

Q: Is the ERP for medical technology qualified for computer system validation?

Yes, the ERP industry solution YAVEON ProBatch is developed according to GAMP 5 requirements. It is therefore considered standard software according to GAMP category 4, which reduces validation effort.

Q: Does our ERP for medical technology meet compliance requirements?

Our ERP for medical technology is developed according to GAMP 5 requirements and meets the important regulatory requirements of the industry.

Q: Is it possible to validate an ERP system in the public cloud?

In principle, it is possible to operate a validated ERP system in the public cloud. However, some individual requirements need to be discussed and clarified.

Q: How is the ERP system for medical technology integrated with other systems that we already use?

Together with you, we will support you in the implementation of Business Central and our medical technology solution. In doing so, we will draw on our project methodology "ProCedures", which has proven itself in all our projects for many years.

Q: Are there training materials available to help my employees use the ERP system for medical technology?

In addition to our comprehensive online help, there are also various training videos available to make the introduction to the new software as smooth as possible for all users.

Q: Are regular updates and new features provided to keep up with the changing requirements of the medical technology industry?

YAVEON, like Microsoft, provides regular updates to always stay up to date. In addition, we are also constantly working on expanding our product portfolio to offer you the most comprehensive solution possible.

Validation-ready ERP industry solution
Developed according to GAMP 5
Meets the requirements of GMP, MDR, and the FDA

Various data visualizations and equipment from medical technology

Challenges our ERP For the medical technology Helps to solve

Strict regulations

Medical Device Regulation (MDR), Good Manufacturing Practice (GMP) and more - our ERP for medical technology meets the requirements of the relevant regulations.

Validated ERP

ERP for medical technology is designed for the regulated environment and developed according to GAMP 5. As the solution is considered standard software (GAMP category 4), this reduces the workload for validation.

Increasing demand

With an increasingly aging population, the demand for medical equipment is growing. You can invest the valuable time saved by using our ERP system in new developments.

Audits

Software audits are an important part of the medical device industry - and a challenge. With a validated implementation procedure and transparent processes, audits can be approached calmly.

Trace lots

If a product does not meet your quality standard, you can easily track lots if required—uncomplicated, and with no gaps. For a quick response when you need it.

Check quality

The demands on products in the medical technology industry are particularly high, and the areas of operation are sensitive. With our ERP, you always have an eye on quality control.

Our ERP references in medical technology

The following companies have successfully deployed our ERP for medical technology.

Menicon
Bort Medical

Menicon

„In addition, we wanted our ERP partner to be a well-established company with adequate resources and a significant number of available consultants. This provides cover for vacation periods or in the event of illness."

Michael Bachmann Read more

Bort Medical

„YAVEON works well for many of our customers, and which argument could be better than a personal recommendation?"

Samuel Erz Read more

Advantages of our ERP system for the medical technology

Work intuitively Comply with regulations Secure, high-quality data Pass audits Satisfied costumers Fast respons Maximum quality Keep an overview Fulfill customer wishes

Work intuitively

With a familiar interface.

Our ERP system for medical technology is based on Microsoft Dynamics 365 Business Central. You benefit from a solution in the signature Microsoft design. So much easier, right?

Perfect for small and mid-sized companies.
Provides an overview of all relevant business processes
Automated processes and reduced workload.
More time to achieve sustainable success and growth

Conclusion: Users don’t need to learn how to use an unfamiliar interface. Instead, they start using the solution intuitively.

Comply with regulations

Fulfilled regulations - satisfied inspectors

As you work more transparently, and automated using scanners, you meet the requirements and comply with the strict regulations of the medical technology industry.

Integration of the logistic scanner processes
Optimized for cooperation with contract manufacturers
Choose the most suitable implementation model

Conclusion: With our ERP for medical technology, you’ll meet the requirements of MDR and those of the FDA.

Secure, high-quality data

Reliable and secure data of the highest quality

The accurate capture and storage of data is a prerequisite for being able to trace and document processes when required. The change controls in the audit trail make this possible. Providing you with peace of mind.

Compliance with the respective regulations
Free parameterization of critical data
Protective mechanisms at field level
Documentation of changes and the cause

Conclusion: Transparent processes, labeling, and seamless traceability of changes—made easy with our medical technology solution.

Pass audits

Pass computer system validation audits

To meet computer system validation requirements, GAMP 5 requirements must be met. Our ERP industry solution for medical technology is developed precisely according to these requirements. And what about the specifications of GxP critical processes? Done. Of course.

Product documentation and validation process templates
Support of change process and update scenarios
Adaptation of our system to your validation specifications
Compliance with GMP requirements with GMP relevant documents
Advice from our experienced consultants
Developed according to GAMP 5: Meets the specifications for the introduction of a validated ERP system

Conclusion: You will meet the strict requirements of the auditors easier and safer with our ERP.

Satisfied costumers

Satisfied customers thanks to maximum quality and security

Maximum security with reduced workload and more transparency right from goods receipt—made possible with quality assurance that meets compliance requirements. Our ERP industry software enables you to meet quality criteria at all times:

Quality assurance and testing accuracy specifications per product
Manage test plans and means and create certificates of analysis
Automatically create inspection orders based on the process, and inspect semi-finished or finished goods
Monitoring of cleanrooms or equipment and management of stability tests
Adherence to Audit Trail, regulations, and compliance.
Incoming goods inspection of your raw materials
Avoid errors from the start thanks to quality constraints

Conclusion: You can meet your customers’ stringent requirements more easily with our ERP for medical technology.

Fast respons

Respond incredibly fast when required

With a clear overview of your lot status, you can easily trace lots back if necessary. Batch traceability reduces errors, increases safety, and facilitates operation, especially in batch handling—for maximal traceability along your entire supply chain.

Check which lot was used at any specific time, under which conditions, and for which purpose
Lot and serial number tracing
Lot status and characteristics management
Changes to lot info only by authorized persons and in the permitted process step
Splitting and mixing of batches, as well as authorization control
Takes into account the entire flow of goods
Complete, detailed, and multi-level lot traceability
Authorization control depending on lot status

Conclusion: When a callback is needed, it has to be quick. Serial numbers and lot traceability make it possible and reliable.

Maximum quality

Successful business relationships thanks to highest product quality

Are your suppliers an essential part of your supply chain? Do regulations such as ISO, FDA, or GMP require you to monitor and audit your suppliers? With our ERP for medical technology, you can easily meet these requirements:

Configurable supplier qualification with hard and soft criteria
Automated evaluation of schedule and quantity adherence
Capture of soft criteria for evaluation
Quality qualification via the testing system based on the delivered products
Integration of risk monitoring

Conclusion: When excellent and efficient cooperation with suppliers is critical to your organization’s success, then it’s ideal that you can do all this with our ERP solution.

Keep an overview

Warehouse and logistics management - run smoothly, with a clear overview

If you lose track of your warehouse and logistics management, chaos is sure to follow. It is critical that manufacturing companies stay on top of things. This is how our ERP supports you:

A comprehensive logistics solution - without interfaces to warehouse management systems
Separation of storage areas such as BTM or cold storage is possible
Control station for your shipping processing and mapping of putaway strategies
Quarantine, restricted, and other batch statuses are taken into account
Extensive availability calculation regarding batch status and rules
Stocks and lot data can be viewed in real-time
MDE solution for mapping relevant logistics and manufacturing processes
Management of load carriers & inventory processing
Mobile-ready

Conclusion: Logistics processes are complex - but so important. ERP facilitates these processes.

Fulfill customer wishes

Satisfy customers with innovative research

Your goal is to meet customer requirements in the long term. You need to meet expectations while continuing to manufacture at a profit. ERP for medical technology helps:

Develop and manage recipes/bill of materials for new products
Version management of your recipes and parts lists
Selectively release recipes for manufacturing
Calculate costs of new products directly in the system
Consideration of all relevant product features
Preparation and shipment of samples

Conclusion: New ideas, innovative products, satisfied customers - all this is easier with ERP.

Combine our ERP system seamlessly with other solutions

Our ERP system for medical technology is versatile. It becomes even more so if you add other options. The most suitable include:

ESCM to exchange data with partners and suppliers.

DMS to process content and documents transparently and automatically

Analyze data intuitively, correctly, and in a visually appealing manner with Microsoft Power BI.

This is what our ERP-Software for medical technology looks like

Screenshot of the quality control function of the ERP medical technology solution

Screenshot of the lot management function of the ERP medical technology solution

Detailscreenshot Function Warehouse Management

Microsoft ERP meets ERP industry solution

Are you looking for more in-depth information on our ERP system? You have come to the right place.

In the whitepaper on our ERP system for the medical technology industry, you will learn

why the industry solution for medical technology makes your everyday work easier,
what highlights await you
why you are safely positioned for the future, and much more.

Mockup Whitepaper ERP Medical Technology

Computer system validation in the cloud - is this possible?

Whether to run your ERP system for medical technology on-premises or in the cloud is up to you. However, cloud solutions are increasingly looking like the future, and ever more organizations are opting for this. But is that compatible with validation?

Validated ERP implementation in the private and public cloud

A private cloud fulfills the necessary specifications to implement an ERP system in a validated manner. You or your software provider decide both on access to the data and on updates - and this is where the challenge lies, as updates must be carried out within the scope of the permitted computer system validation. This requires some preparation and individual coordination, some of which is handled by an external inspector. Conclusion: Validation in the public cloud is possible in principle, but under special conditions. Together we will find your way into the cloud!

FAQs: Answers to the most important questions about our medical technology erp

What is an ERP for the medical technology industry?

An ERP system for the medical technology industry is a highly specialized software solution that integrates the complex operational and business requirements of companies in this sector. It provides a comprehensive range of functions ranging from procurement and production to warehouse management and sales. Additionally, it includes industry-specific modules such as batch tracking, quality management, and compliance management.

These tailored ERP systems are crucial to ensuring efficient resource utilization, improved production planning and control, and compliance with strict safety and quality standards in the medical technology industry. By integrating various business processes, they enable companies to increase operational efficiency while meeting regulatory and customer requirements.

Why is an industry-specific ERP solution important for my medical technology company?

Is the ERP for medical technology qualified for computer system validation?

Does our ERP for medical technology meet compliance requirements?

Is it possible to validate an ERP system in the public cloud?

How is the ERP system for medical technology integrated with other systems that we already use?

Are there training materials available to help my employees use the ERP system for medical technology?

Are regular updates and new features provided to keep up with the changing requirements of the medical technology industry?

Why YAVEON

5 locations, more than 550 customers, 200+ employees and a global partner network. Due to years of experience, we stand for maximum quality and satisfied customers.

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Industry expert

Our portfolio is based on years of experience in the process industry and offers validated solutions in the regulated environment.

Available worldwide

Thanks to our international partner network, our solutions are established on the global market.

Everything from a single source

Thanks to well-known solution partners such as Microsoft or d.velop, we offer a product portfolio that is seamlessly integraded and does not create isolated solutions.

Tailored projects

From entry-level packages for startups and small businesses to individual projects for medium-sized companies – we have the right, scalable solution.

You have questions? We have the answers.

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