The Best Medical Device Manufacturing Software
Drawing on over 25 years of expertise, we’ve curated this guide, ranking medical device manufacturing software with a focus on critical features like risk management and product traceability.
- Multi-entity support
- Multi-warehouse inventory management
- Mobile accessibility
- Quick record creation and retrieval through documents module
- Industry-specific tools like defect tracking
- Regulatory reporting and compliance oversight
- Free trial available
- Initial learning curve
- Workflows can feel constrained
Medical device manufacturing software is a specialized tool used to design, produce, and manage the lifecycle of medical devices, ensuring compliance with regulatory standards. We used our software review methodology to rank the top options on the market today.
- 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
- SAP Business One: Most Scalable Option
- Infor CloudSuite: Best for Complex Manufacturing
1 Acumatica - Best Overall
Why we chose it: Acumatica is our top choice for medical device manufacturing, thanks to its targeted features for the sector’s complex requirements. Its strong compliance and quality control capabilities ensure that medical devices meet stringent regulatory standards. The platform’s traceability and inventory management features further enhance product integrity, essential for managing intricate supply chains and production processes.
Being cloud-based, Acumatica offers the flexibility and scalability needed for manufacturers with diverse and global operations. Its project and product lifecycle management tools streamline the development and launch of new devices, ensuring timely and within-budget completion. The ability to customize and integrate with other systems makes Acumatica a versatile solution, adept at tackling the unique challenges of medical device manufacturing.
2 QAD EQMS - Best for Enterprises
Why we chose it: We found QAD EQMS 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.
3 xTuple - Best Customization Options
Why we chose it: xTuple made our list because it’s an open-source platform, offering unparalleled customization options that cater to medical device manufacturers. This flexibility allows businesses to tailor the software to fit 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.
4 ECI M1 - Best Make-to-Order Support
Why we chose it: ECI M1 excels in providing 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 with high efficiency and precision. 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.
5 Dynamics 365 Business Central - Best Product Ecosystem
Why we chose it: We went with Dynamics 365 Business Central for its integration 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.
6 SAP Business One - Most Scalable Option
Why we chose it: We picked SAP Business One as a scalable option for medical device manufacturers with growth aspirations. The software’s flexible architecture and modular design allow businesses to start with the core functionalities and add more features and modules as they grow. This scalability ensures manufacturers can manage increased complexity and higher volumes without transitioning to a new ERP system.
Additionally, SAP Business One’s global reach and multi-language, multi-currency capabilities make it suitable for manufacturers looking to expand into international markets. The software’s strong analytical and reporting tools provide valuable insights that can drive strategic decision-making and support sustained growth, catering to scalable, expanding manufacturers in the medical device sector.
7 Infor CloudSuite - Best for Complex Manufacturing
Why we chose it: 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.
Medical device manufacturers have many of the challenges of standard manufacturing, including financial management, supply chain control, sales and customer relationships, and productivity management. But, what makes the medical device manufacturing industry unique from an enterprise data management perspective is the amount of standards and regulations that must be observed.
Because of these standards, there is an additional layer of complexity in managing compliance and quality control. ERP systems bring together the tools to meet these challenges. This article will help you understand the features of an ERP system that are available to medical device manufacturers.
What Is Medical Device Manufacturing Software?
Medical device manufacturing systems help manage the production and regulatory compliance of health devices.
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.
Medical Device Manufacturing Software - Key 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
The impact of operating in a highly regulated industry is something your medical device manufacturing business must deal with 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 specifically developed 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 against a set of standards. It can include planning, inspections, document tracking, product specifications, deviation tracking, parts approval tracking and testing.
Traceability is a significant factor as well. Inventory management consists of tracking each SKU, serial number, and lot number. This allows 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 doing market research. This type of software helps track costs and identify where improvements can be made in the R&D process to ensure you have the most effective processes in place.
Key Features of Medical Device Software
Manufacturing Management
Managing the work done on the manufacturing floor is a big job. Important modules for managing that work include:
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Purchasing control. Keep tabs on your suppliers, the quality of parts supplied by vendors, and prices from vendors. Order as needed or set up automatic reorder points. Integrating with order entry allows you to order parts and materials based on incoming orders, thus reducing the inventory you store in your warehouse.
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Warehouse management. Track the flow of products in/out of the warehouse. Understanding where those items are at any given time is critical whether it is parts or finished materials. Have multiple locations in the warehouse for a SKU? Easily transfer products between locations. Also, track inventory set aside for specific customers or orders until those are ready to be fulfilled.
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Shipping and logistics. Integrate with common shipping companies like UPS and FedEx or easily schedule pick-ups from third-party shipping companies. If you deliver your product using internal staff, schedule those deliveries in the system.
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Shop floor scheduling. Schedule what is to be manufactured and when. This allows you to flex machines to sneak in a rush order and know where each order is at any given time. This helps with scheduling orders and staff.
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Bill of materials. Import bills of material from your design systems for manufacturing. Make changes and updates to the BOM as needed.
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Job costing. Track the costs associated with each order. Whether using a paper traveler to track time and materials or a computer system throughout the shop floor, you can track the labor hours and equipment costs for specific jobs. Along with the materials costs, you can better understand the profitability of each job/order.
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Order planning. Expect the expected and the unexpected. Track order histories and trends to know when to order more materials to meet demand. This will help you maintain inventory for current demand and better plan for future demand. Also helps you with planning your cash flow.
All of the features above will improve your time to market, allowing you to make a quality product, using quality vendors, and put the product in your customers’ hands promptly.
Sales and CRM
Integrated CRM and sales software will allow you to prospect new customers, retain current customers and reach out to former customers. Create sales orders which are then transferred to manufacturing. Track customer history to see what they had purchased, when, and what they paid.
Create mass mailings or emails to customers based on their purchase, location, or buying habits.
Service Management
Stand by the products you sell by maintaining a service management system. This allows you to track warranty and service work, track product histories for service trends, and manage RMAs. Additionally, tracking of service work allows you to work better with the manufacturing and engineering departments to create the best product possible.
Financial Management
Financial management functionality is the piece that brings all of the modules together. There are systems available that handle just the manufacturing function, but integration with your financials can help you better control your costs of labor and materials.
The financial management system will allow you to better manage your payables by associating payables transactions with purchase orders and invoices. Associate invoices in the accounts receivable and track transaction and payment history by customer.
The financial management system will also help you with budgeting and forecasting. It is important to know where you are now and where you have been and to plan for the future. Easily create budgets by company, division, and department and roll that information into an overall budget. Also create strategic forecasts allowing you to better plan for developing new products.
The financial management system includes business intelligence tools allowing management to track key performance indicators, view financial information about the company through management dashboards, and keep a pulse on the organization’s financial health. Having accurate data at your fingertips allows you to make better decisions going forward.
MISys Manufacturing software is a fully integrated MRP system that can streamline a manufacturer’s process from inventory, BOM, shop floor control, and more.
Taking the Next Steps
If you are at the point where you’d like to discover software options and providers who can assist with achieving medical device manufacturing software, we can help. Through a brief phone call, our software specialists will look to better understand your business and software needs to help you locate a handful of solutions that can address the issues you are currently experiencing. Get started today!
