Medical Device and Instrument Industry ERP Solutions

Medical factory and production indoorManufacturers in the medical device and instrument industry are challenged with a variety of regulatory compliance and government mandated requirements that add cost and risk to their business. They must maintain strict quality management and detailed product documentation to meet customer specifications and regulatory requirements. Special production techniques, materials, and packaging for medical products force companies to keep stringent control over engineering and shop floor operations. The ability to create detailed work orders and access real-time data instantly is critical to production. Manufacturers need accurate, reliable information about operations, device histories, and costs. Infor SyteLine is a comprehensive software solution that includes the manufacturing, inventory control, and quality assurance capabilities needed by companies to succeed in this industry. With Infor SyteLine, your company can track the movement of materials and parts from receipt to shipping and ensure that products meet or exceed the standards required by customers and by regulatory agencies. Using Infor SyteLine, you can access files quickly for informed decision making, analyze in-depth reports, manage costs and data, and monitor business processes. Lean manufacturing features ensure you deliver on-time while Infor SyteLine’s integrated quality management system helps you easily collect, control, and analyze product data.

Medical device manufacturers must also bring innovative, new products to market rapidly in order to stay ahead of the competition. This requires moving product through the design and prototyping phase and regulatory approval process to manufacturing production and quality control. Infor SyteLine’s Product Lifecycle Management (PLM) capabilities assists in obtaining and sustaining ISO certifications, the ability to maintain electronic records and quality standards, and the use of workflow guided transactions all help to shorten the time to market. Because this ERP solution is designed and built to meet the requirements of the medical device industry out of the box, you will require fewer modifications, making implementation time quicker and a faster return on investment.

ERP Software Solution for the Medical Device and Instrument Industry

Infor SyteLine can help companies within the medical device and instrument industry significantly improve their production and profitability with features such as:

  • Shop Floor Control
  • Cost Accounting (Standard, Actual, or Average)
  • Multi-Currency Accounting
  • Engineering and Product Lifecycle Management
  • Material Requirements Planning
  • Combined Bill of Materials and Routing
  • Lot and Serial Number Traceability
  • Device History Record
  • Help Desk/Customer Complaint Tracking
  • Return Material Authorizations (RMAs)
  • Quality Management

Infor ERP also offers an integrated quality management system that meets the following standards:

  • FDA cGMP
  • QSR (Medical Device Model for Quality Assurance)
  • ISO9001/ISO9002 (Quality System-Model for Quality Assurance)
  • ISO13485 (ISO9001 Biomedical particular requirements)
  • EN46001 (European Medical Device for Quality Assurance)
  • 21 CFR Part II (Electronic Records & Signatures)

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