8.8
Editor’s Rating:
Best Overall
Acumatica Cloud ERP: Data Analysis Receivables
Acumatica Cloud ERP
  • Multi-entity support
  • Multi-warehouse inventory management
  • Mobile accessibility
8.6
Editor’s Rating:
Best for Enterprises
QAD EQMS: QAD EQMS Dashboard
QAD EQMS
  • Quick record creation and retrieval through documents module
  • Industry-specific tools like defect tracking
  • Regulatory reporting and compliance oversight
8.6
Editor’s Rating:
Best Customization Options
xTuple: KPI Dashboards
xTuple
  • 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.

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.

Best Overall:
Acumatica Cloud ERP

Acumatica Cloud ERP: Data Analysis Receivables
Acumatica Cloud ERP: Support Manager Dashboard
Acumatica Cloud ERP: Project Dashboard
Acumatica Cloud ERP: Staff Appointments on Map
Acumatica Cloud ERP: Field Services Tech Dashboard
Acumatica Cloud ERP: Production Manager Dashboard
Acumatica Cloud ERP: Warehouse Manager Mobile Dashboard
Acumatica Cloud ERP: Controller Dashboard
What We Like
Open architecture for rapid integrations
Multi-entity support
Mobile accessibility
What We Don’t Like
Must schedule a consult for pricing calls
High learning curve
Tedious setup
Overview
Price Range: $$$$
Starting Price: $1,800/month
Client OS: iOS, Android, Web
Deployment: Cloud or On-Premises

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.

Best for Enterprises:
QAD EQMS

QAD EQMS: QAD EQMS Dashboard
QAD EQMS: QAD EQMS Reports
QAD EQMS: QAD EQMS Audit Types
What We Like
Responsive customer service
Quick record creation and retrieval through documents module
What We Don’t Like
CAPA module could be more configureable
Limited global search functions
Overview

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.

Best Customization Options:
xTuple

xTuple: KPI Dashboards
xTuple: Application Homepage
What We Like
Free trial available
New eCommerce additions
Platform agnostic
What We Don’t Like
Complex reporting
Learning curve
Workflows can feel constrained
Overview
Price Range: $$$$
Starting Price: $175/user/month
Client OS: Windows, macOS, Linux
Deployment: Cloud or On-Premises

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.

Best Make-to-Order Support:
Dynamics 365 Business Central

Dynamics 365 Business Central: General Leger Entries
Dynamics 365 Business Central: Dashboard
Dynamics 365 Business Central: Customer Management
What We Like
Combined ERP and CRM
Similar interface to MS Word and Outlook
Integrations with Microsoft applications
What We Don’t Like
Not ideal for complex manufacturing needs
May require extensive training
No free version
Overview
Price Range: $$$
Starting Price: $70/user/month
Client OS: Web
Deployment: Cloud or On-Premises

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.

Best Product Ecosystem:
Dynamics 365 Business Central

Dynamics 365 Business Central: General Leger Entries
Dynamics 365 Business Central: Dashboard
Dynamics 365 Business Central: Customer Management
What We Like
Combined ERP and CRM
Similar interface to MS Word and Outlook
Integrations with Microsoft applications
What We Don’t Like
Not ideal for complex manufacturing needs
May require extensive training
No free version
Overview
Price Range: $$$
Starting Price: $70/user/month
Client OS: Web
Deployment: Cloud or On-Premises

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.

Most Scalable Option:
SAP Business One

SAP Business One: Sales Analysis
SAP Business One: Enterprise Search
SAP Business One: Cash Flow
What We Like
Highly customizable
Improved decision-making capabilities via extensive BI
Multi-currency/multi-language support
What We Don’t Like
Requires phone consult for pricing
Setup usually requires help from a Value Added Reseller (VAR)
No payroll module
Overview
Price Range: $$$$
Starting Price: $410/user/year
Client OS: Windows
Deployment: Cloud or On-Premises

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.

Best for Complex Manufacturing:
Infor CloudSuite Industrial

Infor CloudSuite Industrial: Product Configuration
Infor CloudSuite Industrial: Inventory
Infor CloudSuite Industrial: PL Projection
Infor CloudSuite Industrial: Estimate
Infor CloudSuite Industrial: Customer Service Homepage
What We Like
Multi-site and multi-company support
Built-in business intelligence
Comprehensive supply chain management
What We Don’t Like
Limited QMS module
Difficult upgrades
Steep learning curve for new users
Overview
Price Range: $$$$$
Starting Price: $25,000/user (perpetual license)
Client OS: Windows, Web
Deployment: Cloud or On-Premises

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.

Acumatica Production Manager
Acumatica allows manufacturers to track production processes and progress.

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:

  • 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.

  • 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.

  • 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.

  • 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.

  • Bill of materials. Import bills of material from your design systems for manufacturing. Make changes and updates to the BOM as needed.

  • 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.

  • 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.

Microsoft Dynamics 365 CRM
Microsoft Dynamics 365 includes an integrated CRM system.

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!

All Products

No products found
Acumatica Cloud ERP Screenshot

Acumatica Cloud ERP

★★★★★
★★★★★
(22)
Acumatica is a renowned platform in the ERP world. It offers accounting, distribution management, CRM, manufacturing, and more modules. Acumatica supports unlimited users, with pricing based on the resources and modules your company uses.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$1,800/month
Client OS
iOS, Android, Web
Deployment
Cloud or On-Premises
QAD EQMS Screenshot

QAD EQMS

★★★★★
★★★★★
(4)
QAD EQMS, formerly MQ1, is a software solution tailored for quality and compliance management in manufacturing settings. It includes document control, compliance oversight, corrective and preventive actions (CAPA), and risk assessment. Additionally, the software facilitates regulatory reporting, audit coordination, and supplier evaluations. It’s widely adopted by manufacturing firms in various sectors, including life sciences and high-tech. QAD EQMS helps enhance product quality while reducing the costs linked to defective products.
xTuple Screenshot

xTuple

★★★★★
★★★★★
(9)
xTuple is an affordable manufacturing ERP software that supports distribution, accounting, inventory control, and supply chain management. It offers financial and purchasing reports to provide real-time insights into cash flow and production processes.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$175/user/month
Client OS
Windows, macOS, Linux
Deployment
Cloud or On-Premises
Dynamics 365 Business Central Screenshot

Dynamics 365 Business Central

★★★★★
★★★★★
(10)
Microsoft Dynamics 365 Business Central provides finance, human resources, operations, marketing, sales, and more functionalities. It is a part of Microsoft’s suite of enterprise applications and integrates seamlessly with services like Office 365, Power BI, and Azure.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$70/user/month
Client OS
Web
Deployment
Cloud or On-Premises
SAP Business One Screenshot

SAP Business One

★★★★★
★★★★★
(12)
SAP Business One provides comprehensive business management capabilities for small and medium-sized companies. This system provides integrated departmental support for finance, sales, supply chain management, production, project management, and production processes. This software can be deployed on-premise or on the cloud, and accessed from any mobile device through iOS and Android apps. The SAP API Business Hub allows for a wide range of partner integrations.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$410/user/year
Client OS
Windows
Deployment
Cloud or On-Premises
Infor CloudSuite Industrial Screenshot

Infor CloudSuite Industrial

★★★★★
★★★★★
(5)
Infor CloudSuite Industrial (formerly SyteLine) is renowned in manufacturing for its robust bill of materials features, customizable reports, and modern design. The ERP’s key components include advanced planning and scheduling, supply chain management, accounting, and quality assurance.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$25,000/user (perpetual license)
Client OS
Windows, Web
Deployment
Cloud or On-Premises
ORION Medical Devices Screenshot

ORION Medical Devices

The Medical Devices Business Suite is a comprehensive, affordable, full-featured ERP solution targeted at the equipment manufacturing industry. Need for all encompassing pre and after sales service and support; Ability to process returns with RMA accountability and warranty tracking; Integration of purchasing with the complete supply chain process; Need for accurate and timely forecast of customer demands; Ability to maintain brand equity and increase market position through superior quality and
ECI M1 Screenshot

ECI M1

★★★★★
★★★★★
(15)
ECI M1 is a manufacturing ERP designed to manage resources and streamline workflows. Modules include customer and vendor relationship management, job costing capabilities, quality assurance, and inventory control over raw materials, sub-assemblies, and finished goods.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$5,000/month
Client OS
Windows
Deployment
Cloud or On-Premises
Priority ERP Screenshot

Priority ERP

★★★★★
★★★★★
(1)
Priority ERP is a cloud-based business management and ERP software. It stands out due to its broad range of functionalities, covering areas like finance, customer service, logistics, manufacturing, WMS and more. It is designed to cater to businesses of various sizes, from mid to large enterprises, and is especially well-suited for industries like manufacturing, distribution and retail.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Web
Deployment
Cloud Hosted
Deacom Screenshot

Deacom

★★★★★
★★★★★
(3)
Deacom is an ERP software primarily designed for process based manufacturers. It offers features including administrative, accounting, manufacturing, and supply chain management. Deacom is known for its user-friendly interface, accessible across all devices with a browser, and is updated regularly.
Client OS
Windows, Web
Deployment
Cloud or On-Premises
SYSPRO Screenshot

SYSPRO

★★★★★
★★★★★
(15)
SYSPRO is a major developer in the ERP world. Since 1978, it’s built a solid reputation in the manufacturing and distribution sectors. SYSPRO is an ERP software designed for discrete manufacturing and mixed-mode operations.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$199/user/month
Client OS
Windows, Web
Deployment
Cloud or On-Premises
QT9 ERP Screenshot

QT9 ERP

★★★★★
★★★★★
(1)
QT9 ERP is a cloud-based or on-premise software for the life sciences manufacturing sector. Key features include inventory control, accounting, and sales. QT9 ERP also provides tools for effective supply chain management and product delivery acceleration. QT9 ERP integrates directly with [QT9 QMS](/reviews/qt9-qms-software/) to ensure ISO and FDA compliance.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Windows, Web
Deployment
Cloud or On-Premises
IQS Screenshot

IQS

★★★★★
★★★★★
(2)
IQS was a quality and compliance management software system acquired by Cority in 2017. It featured process review tools, compliance reporting, and policy drafting capabilities. It was also available in on-premise and cloud-based formats. Overall, it served to optimize risk reduction and cost effiency across multiple industries.
Client OS
Windows
Deployment
Cloud Hosted
Exact MAX Screenshot

Exact MAX

★★★★★
★★★★★
(1)
Exact MAX is an MRP and order management software. It integrates with Microsoft Dynamics and QuickBooks. It addresses common issues in manufacturing, such as inaccurate inventory and duplicate data entry. Its key features include inventory control, lot and serial tracking, master scheduling, material requirement planning, and sales order processing.
Client OS
Windows
Waypoint Global Suite Screenshot
Waypoint Global Suite is a quality and document management system. Designed by Waypoint Global, this solution was formerly known as Powerway.
Client OS
Windows
Deployment
On-Premises
Horizons Manufacturing Suite Screenshot

Horizons Manufacturing Suite

Horizons Manufacturing Suite (HMS) is composed of a series of modules that enable manufacturing scalability where one can begin by using the Bill of Materials and Production Entry and scale up in use as situations demand. Add Work in Process, Serial and Lot Number control, Material Requirements Planning, Engineering Change Order and Manufacturing Production Scheduling, Router, Shop Floor Control, and a Product Configurator. Bill of Materials with Production (BOM)- including Indented Bill of
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Windows
S2K Enterprise Screenshot

S2K Enterprise

★★★★★
★★★★★
(2)
S2K Enterprise software is a cloud-based ERP software for midsize distributors, manufacturers, specialty retailers, service & repair, and equipment rental businesses. The software offers tailored versions for industries like electronics, food and beverage, and pharmaceuticals.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Windows, Linux, Web
Deployment
Cloud Hosted
VisionCore Screenshot

VisionCore

★★★★★
★★★★★
(1)
VisionCore is an All-in-One ERP application that tightly integrates all modules eliminating the need for your business to purchase multiple applications. VisionCore offers a complete solution for SMB’s that need integrated accounting, ecommerce, CRM and ERP without an enterprise price tag. This integration gives you a very consistent look and feel and cuts the learning time down considerably. Not only does VisionCore include all the major modules you would need to run your business, it can also
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$4,999 (perpetual license)
Client OS
Windows
Deployment
On-Premises
Global Shop Solutions ERP Software Screenshot

Global Shop Solutions ERP Software

★★★★★
★★★★★
(4)
Global Shop Solutions is a manufacturing ERP software with modules for workflow planning, inventory control, CRM, and SPC. It provides options for both cloud-based and on-premise deployment with SaaS licensing.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Windows, iOS, Android, Web
Deployment
Cloud or On-Premises
FlexGen 4 Screenshot

FlexGen 4

★★★★★
★★★★★
(1)
Software 21’s premier Enterprise Solution FlexGen 4 is unique offering fully integrated ERP, CRM, SCM and BI applications designed to enhance manufacturing productivity, Supply Chain efficiency and overall customer satisfaction. FlexGen 4 is a real-time, highly configurable software environment which has been engineered to fit the unique business management processes found in companies building products such as computers, avionics, aerospace components and medical equipment. FlexGen 4 provides
Starting Price
$25,500 (perpetual license)

We searched and searched, but we couldn’t find any products in our database that match your criteria. Perhaps our team of software experts can help? They’d be happy to provide a list of free recommendations that meet your exact requirements.

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