The Best Medical Device Manufacturing Software
Medical device manufacturing software is a specialized tool used to design, produce, and manage the lifecycle of healthcare equipment. We tested and ranked the best systems that focus on compliance and corrective and preventative actions (CAPA).
- Open architecture for rapid integrations
- Multi-entity support
- Mobile accessibility
- Responsive customer service
- Quick record creation and retrieval through documents module
- Can be tailored to specific industries
- Free trial available
- New eCommerce additions
- Low total cost of ownership
We used our software review methodology to rank the top options on the market today, including Acumatica, QAD EQMS, and xTuple.
- Acumatica: Best Overall
- QAD EQMS: Best for Enterprises
- xTuple: Best Customization Options
- ECI M1: Best Make-to-Order Support
- Dynamics 365 Business Central: Best Product Ecosystem
- Infor CloudSuite: Best for Complex Manufacturing
Acumatica - Best Overall
Acumatica ‘s compliance functionality integrates with its cloud-based ERP system, allowing for real-time data collection, automated reporting, and secure access to critical information. The system enables you to maintain accurate records, track product lifecycles, and ensure adherence to FDA guidelines and ISO standards.
Before manufacturing starts, Acumatica verifies the approved supplier lists and quality certifications to ensure the right materials are used. Then, during production, the system enforces in-process quality checks, flagging potential issues before they reach the final stage.
Acumatica records every step of production, from raw material intake to final product inspection. If any error occurs throughout the process, this ERP triggers corrective and preventative actions (CAPA) workflows, logging all changes in an audit trail for review. The software can also generate compliance reports on demand for audits and regulatory submissions.
QAD EQMS - Best for Enterprises
QAD EQMS is best for mid-sized to large medical device manufacturers due to its critical features for operating at scale in a heavily regulated industry. These include a document control system that gives teams across the enterprise access to the latest revisions and engineering changes. This is crucial for maintaining compliance with FDA and ISO regulations, which demand meticulous traceability throughout the device lifecycle.
The software’s integrated quality management system, with corrective and preventive actions (CAPA), supplier quality management, and continuous improvement modules, is particularly useful for mid-sized to large enterprises. These features enable manufacturers to proactively manage quality across the entire supply chain, from raw materials to finished products.
xTuple - Best Customization Options
xTuple is an open-source platform that offers unparalleled customization options that cater to medical device manufacturers. This flexibility allows businesses to tailor the software to their specific processes, workflows, and compliance requirements. The ability to modify and extend the system ensures that it can adapt to the evolving needs of the business, providing a long-term solution that grows with the company.
Beyond its customization capabilities, xTuple’s active community of users and developers contributes to a rich ecosystem of plugins, extensions, and integrations, further enhancing the software’s versatility. This collaborative environment fosters innovation and ensures that users have access to a wide range of solutions to meet their changing needs, solidifying xTuple’s position as the best option for customization in the medical device manufacturing space.
ECI M1 - Best Make-to-Order Support
ECI M1 provides robust support for make-to-order manufacturing processes, a common requirement in the medical device industry. Its specialized job costing, scheduling, and tracking tools enable manufacturers to manage custom orders efficiently and precisely. The software’s ability to provide real-time data on job status, material availability, and production timelines helps businesses minimize lead times and improve customer satisfaction.
The system’s integrated CRM and ERP functionalities further streamline the make-to-order process, from initial customer inquiry through production and delivery. This seamless integration ensures that all departments access the same up-to-date information, facilitating better communication and coordination across the organization. ECI M1’s focus on the specific needs of make-to-order manufacturers makes it the top choice for medical device companies specializing in custom products.
Dynamics 365 Business Central - Best Product Ecosystem
Dynamics 365 Business Central offers strong integrations within the Microsoft ecosystem, including Office 365, Outlook, and Azure. This integration facilitates smooth workflows and communication, allowing manufacturers to leverage their existing Microsoft infrastructure. Additionally, its manufacturing module handles complex BOMs, ensures product quality and traceability, and supports FDA compliance, ISO 13485 standards, and other global regulatory requirements.
Additionally, Business Central provides tools for documentation, audit trails, and compliance tracking, ensuring manufacturers can maintain and demonstrate compliance effectively. Business Central’s supply planning tools help maintain inventory levels, forecast demand, and plan material purchases, essential for uninterrupted production and delivery of medical devices.
Infor CloudSuite - Best for Complex Manufacturing
Infor CloudSuite Industrial is specifically designed to handle the complexities of manufacturing processes typical in the medical device industry. Its advanced planning and scheduling capabilities, detailed traceability, and quality management features ensure manufacturers can maintain high quality and compliance standards. Additionally, we found CloudSuite Industrial efficient at managing complex product configurations.
The platform’s industry-specific functionalities, including support for FDA compliance and medical device reporting, make it a comprehensive solution. CloudSuite Industrial’s focus on addressing the unique challenges of complex manufacturing processes, combined with its cloud-based deployment options, ensures that businesses have the agility and control needed to succeed in this demanding industry.
What Is Medical Device Manufacturing Software?
Medical device manufacturing software is designed to streamline and optimize the production of implantable devices, diagnostic equipment, wearables, and surgical instruments. It often includes ERP components tailored to the industry, such as traceability features and regulatory compliance.
Medical devices are often subject to regulatory agencies such as the U.S. Food and Drug Administration (FDA), or International Organization for Standardization (ISO). Specialized manufacturing systems aim to ease compliance and improve profits.
Key Features
- Regulatory Compliance Management: Supports adherence to FDA and EU MDR regulations for product identification and ensures electronic records and signatures meet all requirements.
- Quality Management: Captures deviations and defects in the manufacturing process for quality control.
- Traceability and Tracking: Ensures complete product lifecycle visibility, supporting serialization and recall management.
- Device History Record (DHR) Automation: Automates and manages medical device production history records, reducing paper-based tracking.
- Expiration Date and Shelf-Life Tracking: Ensures components and final products are sold before expiration.
Benefits
ERP software seeks to link financial and operational “back-office” functionalities with operational and “customer-facing” technology. Medical device manufacturing ERP software solutions offer a comprehensive approach to enterprise data information systems.
An ERP system’s base benefits include:
- More efficient workflows,
- Visibility into processes for continuous improvement,
- Prevention of data re-entry,
- Robust reporting for enhanced operational and financial visibility,
- Improved data security, and
- Facilitation of collaboration opportunities.
Compliance With Quality Control Standards
Your medical device manufacturing business must deal with the impact of operating in a highly regulated industry daily in many different ways. The FDA, of course, not only governs food and pharmaceuticals but also has specific standards for device manufacturers. ISO 13485 is a certification developed explicitly for medical device manufacturers, which contains specific requirements for manufacturing, installation, and servicing. ISO 13485 calls for:
- Implementing a quality management system,
- Risk management,
- Statutory and regulatory compliance,
- Process validation, and
- Effective product traceability and recall systems.
Ultimately, compliance is a matter of quality control management and reporting standards. It can include planning, inspections, document tracking, product specifications, deviation tracking, parts approval tracking, and testing.
Traceability is also a significant factor. Inventory management tracks each SKU, serial number, and lot number, allowing you to identify where and when each item was manufactured.
Research and Development
For many medical device manufacturers, a product’s life starts in the research and development stage. You can spend many hours designing and engineering the products, testing, and conducting market research. This software helps track costs and identify where improvements can be made in the R&D process to ensure you have the most methods in place.
