ERP for Medical Device Manufacturers

Surgeons performing an operation with advanced medical devices

AX for Pharma 365™ drives precise operations supporting the sales, design, manufacture, distribution, and usable life of Medical Devices

The medical device industry is advancing with extraordinary speed.

It delivers life-enhancing innovations built on the power of automation and wireless technology. And while time-to-market is critical, safety can never be compromised. Quality and reliability must be tightly woven into every step throughout product design, manufacturing, distribution and maintenance.

When quality is a strategic priority, there is no room for human error. Your organization needs a digital foundation designed to connect and control the data, processes, and regulatory requirements, like reporting, that guarantees unremitting quality.

AX for Pharma 365™ is the cloud-based ERP for the medical device industry. It is specifically designed to meet the exacting needs of companies like yours. Our medical device manufacturing software will connect and control all of your business processes. Natively integrated with Microsoft Dynamics 365 business management platform, AX for Pharma 365™ drives efficient operations supporting the sales, design, manufacture, distribution, and usable life of medical devices.

AX for Pharma 365™ is purpose-built ERP software. It provides a clear picture of financial and operational performance in real time and streamlines compliance to meet the strict regulatory controls on medical devices.

Our AX for Pharma 365™ implementation and support team has deep expertise in leading successful installations of Microsoft Dynamics for medical device manufacturing. They have a firm grasp of Microsoft technologies as well as real-life experience with the product design, manufacturing, and distribution challenges you face every day.

For more information, please download our eBook:
How Life Science Companies Can Improve Their Market Value

Advanced Quality Control With Medical Device Manufacturing ERP Software

  • Through AX for Pharma 365™’s end-to-end ERP solution, the AXP 365 Advanced Quality Management™ module, LIMS (Laboratory Information Management System) monitors quality control and sampling for critical raw materials and components, and manufactured products. The ECM (Engineering Change Management) module assesses impacts, revises workflows, and documents changes across the entire product lifecycle to reduce production disruptions.
  • The quality system functionality in our ERP for medical device manufacturers fully supports compliance with the FDA's 21 CFR standards.
  • GMP (Good Manufacturing Practices) meets the quality system requirements to design, produce, and distribute medical devices that are safe and effective.
  • Working in concert with Microsoft, AX for Pharma 365 ™ protects data from end-to-end ensuring full confidence in tight data security that will meet rigorous compliance requirements.

Better Enterprise Resource Optimization Through ERP Systems

  • AXP 365 Manufacturing Execution System™ (MES) streamlines manufacturing to automate production processes from end to end and delivers accurate real-time visibility into your supply chain.
  • AXP 365 Project Operations effectively manages purchasing, production, sales, distribution and maintenance of complex Medical Devices.
  • AX for Pharma 365™ Enterprise Asset Management (EAM) supports proactive maintenance.
  • Product Data Management (PDM) and Product Lifecycle Management (PLM) trace medical devices’ history.

Unified Process and Data Management

  • AX for Pharma 365™ simplifies financial operations from across the organization to plan, manage, and complete medical device projects on time efficiently and within budget.
  • AX for Pharma 365™ automates Device Master Record (DMR) tracking and documentation. In addition, Device History Record (DHR) details and history are recorded for each medical device lot and unit from manufacturing through distribution to patient use.
  • With AX for Pharma 365™, your organization can take full advantage of Microsoft PowerBI business intelligence to monitor your operational performance and key indicators in real-time.