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ERP Software for Medical Devices

Attain flexibility, control, and scalability in an ever-evolving regulatory environment

What is ERP Software for Medical Devices?

Medical device ERP software provides the required tools to manage quality requirements and compliance for medical device manufacturers. It supports internal communication and allows all departments to collaborate and work in unison.

The medical device ERP delivers industry-specific functionality to accommodate your current and future business needs. In addition, you can conduct rigorous inspections to ensure your products conform to industry-specific operational standards.

What are the Major Challenges in Medical Device Industry?

Disrupted Supply Chain

The pandemic impacted global supply chains, increasing time-to-market and escalating material prices. Yet, the demand for medical devices rose exponentially. As a result, experts suggest there will be a massive disparity between what medical device manufacturers can produce until raw material prices get back to pre-pandemic levels and global supply chains become functional again.

Disrupted Supply Chain
The Age of Highly Regulated Industries

The Age of Highly Regulated Industries

Unregulated devices are not covered by insurance, and therefore patients are skeptical about purchasing them due to cost concerns. Also, medical device manufacturers get shock when they learn more about FDA regulations and other evaluation processes because they are costly and lengthy. Thus, many startup medical device manufacturers don’t apply for getting government approvals.

Imitators and Counterfeiting

One of the biggest concerns for medical device manufacturers is counterfeit products that flood the market within a few months. Responsible medical device manufacturing companies do years of research to design and manufacture a top-notch products. But imitators build products that are poor in quality and may cause severe injuries to the consumers. These replicas are often well-packaged and competitively priced to offset their poor production.

Imitators and Counterfeiting
Ever-increasing Healthcare Costs

Ever-increasing Healthcare Costs

One of the most significant challenges for the medical device manufacturing industry is the rising cost of medical devices. It’s because patients, especially those suffering from chronic conditions, can’t afford medical devices. This situation is compounded by the fact that most medical devices lie outside the purview of traditional insurance coverage. And therefore, the customer base of medical device manufacturing companies is decreasing sharply.

Features of ERP Software for Medical Devices

Comply with High-level Quality Standards

Provide forward and backward bi-directional traceability from source to consumption
Verify the authenticity of specific transitions by operators. Also, the ERP for medical device manufacturers helps generate corrective actions and efficiently handle all steps in the non-conformance process.


Build Excellent Supplier Relationships

Fulfill the needs of your medical device company through advanced governance, controls, and oversight required for ensuring that materials are procured ethically. Sage 300 ERP will allow you to optimize sourcing strategies for raw materials and facilitate the selection of suppliers throughout the purchasing cycle. Partner with suppliers to secure long-term preferential agreements. This way, you can get high-quality materials at affordable costs .

Handle the Design Process

Allow contract manufacturers to finish their work without providing them real-time access to the central repository. Engineering change control allows you to meet the design process needs. Define production resources such as labor, machines, and quality management. Track defects and variances. One of the essential features of Sage X3 medical device ERP is replacing one item with a valid substitute item. Eliminate multiple data copies with real-time CAD integration.

Optimize Material Visibility and Planning

Use requisition approval workflow to manage the purchasing process. Define user restriction by denying or limiting access to the warehouse. Speed up the purchase process by creating RFQ and submitting it to prospective suppliers. The medical device manufacturing software manages the exchange and return of products brought from suppliers. Install lots, stock codes, and bins to prevent the use of discrepant material.

Streamline Production​

Identify and resolve bottlenecks quickly by handling exception alerts and managing real-time, Work-in-Progress monitoring. Identify which task is assigned to which employee, eliminate difficulties, and reduce risks using full audit trail reporting.

Also, medical device ERP aids in eliminating quality issues by checking trends and patterns and getting a 360-degree perspective of labor, raw materials, machines, and quality variables Use planning tools and advanced capacity planning to reduce costs. Now, reserve serials/lots for parent components for issuing materials for finished goods with the top business management software.

Support Repair and Equipment Maintenance

Sage X3 ERP for medical device manufacturers offers lot traceability and serial tracking functionality which provides replacement details, reliable part warranty, and history. It includes details of any subcontracted work, service notes, and configuration history. Keep records of previous maintenance work and customer equipment specifications to meet service-level subcontracted work with Sage maintenance management software.

Minimize Time to Market

Get a comprehensive view of machines, raw materials, labor, and quality variables
Streamline order-taking and generate purchase and factory orders with relevant details using a rule-based product configurator. For design-to-order and complete engineer- requirements, expedite the inquiry processing speed through quotations and estimating functionality. The medical device manufacturing software provides a comprehensive view of standard and non-standard labor and material costs.

Take Your Business Control with Sage X3 ERP

Effortlessly streamline processes and achieve unparalleled business growth

Benefits of ERP Software for the Medical Devices Industry

Sub-contracted Operations and Supply Chain Management

Medical device companies can conveniently monitor and track sub-contract processes, build excellent relationships with partners, minimize operational costs, and control issues with excellent medical device ERP software.

Complete Device History

Create a Device History Record (DHR) that allows medical device companies to pay attention to the rising cost of production and materials, tooling specifications, patient documents, and packaging & labeling.

Post-sale Service and Support

Sage 300 ERP software for medical device manufacturing allows companies to handle complaints, warranty claims, service contracts, and returns along with integrated CRM capability.

Compliance and Quality Management

Sage X3 manufacturing ERP software allows companies to conform to high-level quality standards. It ensures that products conform to required characteristics, operational tolerances, and expected results.

Transaction Audit Trails and Full-lot Traceability

Sage manufacturing ERP software for medical device companies provides full backward and forward lot traceability. This feature maintains a repository of historical transactions over several years.

Inventory Location Procedures and Advanced Order Fulfillment

With its improved order fulfillment feature, Sage X3 medical device ERP software allows medical device companies to meet customer expectations on time. In addition, data stored in a single repository will enable companies to improve visibility into the supply chain, manufacturing operations, inventory, and changing market demand & customer preferences.

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