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Meet market demands through operational excellence and regulatory compliance 

The medical device industry is evolving rapidly, bringing innovations that enhance lives through cutting-edge technologies. While time-to-market is critical, safety can never be compromised, creating a unique challenge: How do you streamline processes without sacrificing non-negotiable quality? 

Every error counts in this high-stakes industry, and there's no margin for human mistakes. Your organization needs a robust digital infrastructure that seamlessly integrates data as well as processes and complies with critical regulatory frameworks, to ensure quality adherence. 

Our medical device ERP is a definitive cloud-based solution engineered specifically for the sector. Designed to meet your industry's stringent requirements, our platform ensures that every facet of your business—from design and manufacturing to distribution and maintenance—is interconnected and managed precisely. 

Our solution is embedded in the Microsoft Dynamics 365 ecosystem and guarantees compliance with FDA CFR 21 Part 11 and GxP guidelines. 

Key Challenges

Lack of standard processes
Lack of standardized processes and manual operations contribute to inconsistent quality and may result in non-compliance, customer mistrust, and financial losses.
Regulatory non-compliance
Disorganized systems, fragmented data, and irregular documentation lead to non-compliance. Companies may face product recalls, reputation damage, and even legal action 
Inefficient supply chain management
Lack of visibility due to inadequate data integration causes inefficient supply chain management, which may lead to inventory overstocking or stockouts causing delays and loss  

Compliance adherence

Automate tracking and documentation needed for Device Master Record (DMR). Track details and the history of each medical device lot and unit from manufacturing through distribution and patient use as required for Device History Record (DHR). Enable compliance with electronic signatures. 

Warehouse management

Track picking, shipment, and distribution with a single scan. Move one or multiple sub-batches or the entire license plate as per the prescribed conditions.

Data security

Use Role Wizard to create custom security roles from privileges, duties, and entry points. Maintain audit trail of current and previous users and improve traceability with logged details of all security changes. 
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Benefits

Enable quality control

Manage quality by automating the quality checks, standardizing the workflows, and centralizing the data. With our ERP for medical devices, you can gain insights to improve continuously and manage risks, ensuring consistent production quality and safety. 

Ensure compliance

Integrate regulatory requirements within the supply chain management and manufacturing process, streamline documentation, and maintain traceability to ensure compliance with FDA 21 CFR Part 11 and GxP guidelines.

Optimize warehouse management

Facilitate on-time pickup, automate re-ordering of raw material, and minimize stockouts and overstocking with medical device ERP software. 

Enhance data security

Integrate data securely and configure roles, permissions, and privileges, while ensuring compliance with regulations and guidelines such as GxP, SOX, and GDPR.

Streamline project lifecycle

Enable real-time project tracking, budget forecast, planning, scheduling tasks, and cross-functional collaboration to enhance transparency and accountability throughout the project lifecycle.

Improve supply chain management

Improve coordination between stakeholders to ensure on-time and cost-effective delivery of products/ medical devices. 

Features

Compliance Management

Compliance Management

Adheres to industry regulations like FDA 21 CFR Part 11 and EU GMP Annex 11. Generates an extensive audit trail for inspection and audits. Enables electronic signature for approvals. 

Traceability

Traceability

Tracks and traces serial numbers for individual devices to facilitate end-to-end traceability and efficient recall management.

Product Lifecycle Management

Product Lifecycle Management

Manages the design and production of medical devices including change management and version control.

Inventory Management

Inventory Management

Tracks components, raw materials, and devices in real-time. Optimizes inventory levels and monitors expiration dates. 

Supply Chain Management

Supply Chain Management

Manages suppliers, procurement, and logistics to ensure timely delivery to the customers.

Frequently asked questions

Can't find what you're looking for?

What ERP features are vital for medical device manufacturers?

The essential ERP features include quality management, compliance, product lifecycle management, and device traceability from production to post-market. Our Medical Device ERP software is designed to cover the typical industry requirements without costly customizations or integrations.

How does an ERP system help with FDA compliance?

An ERP system should help comply with critical regulations such as FDA and EMA guidelines, and GMP standards, through comprehensive audit trails and sophisticated reporting tools. Our Validation Toolkit provides templates and documentation to streamline the system's validation.

How does an ERP support quality control? 

Medical Device ERP with robust quality control modules supports in-process inspections, non-conformance tracking, and corrective and preventive actions (CAPA). 

What are the ERP considerations for global medical device companies?

Global medical device companies should ensure the ERP supports multiple languages and currencies, complies with international regulations, and can handle complex supply chains. 

How can an ERP for medical devices improve operational efficiency?

An effective ERP system streamlines manufacturing processes, reduces waste, improves inventory management, and enhances data visibility. It also ensures compliance with industry regulations and guidelines such as EU GMP Annex 11 and FDA CFR 21 Part 11, ultimately leading to increased productivity and cost savings.

What is the importance of serialization and batch traceability?

Serialization and batch traceability are crucial for recall management and regulatory reporting. Our medical device ERP software offers the unique ability to track and trace each product unit helping you maintain end-to-end traceability.

Resource Center

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    Medical Devices ERP Factsheet

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    Adopt STAEDEAN Life Sciences ERP for resilient supply chain

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    Supply chain failures in the medical devices industry can be fatal. Ensure resilience with STAEDEAN Life Sciences ERP. Discover how.

    Grow your Medical Device company with ERP Excellence

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    Ready for sustainable growth? Learn how our Medical Devices ERP improves operational efficiency, productivity, and agility while being compliant.

    Improving Traceability in Life Sciences Using Sub-Batch Numbers

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    Deep dive into advantages, features, and application of sub-batch numbers for your warehouse management.
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