Manufacturers 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. It is imperative they 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. Medical device manufacturers need accurate, reliable information about operations, device histories, and costs. Infor® SyteLine Medical Device ERP is a comprehensive software solution that includes the manufacturing, inventory control, and quality assurance capabilities needed by companies to succeed in this industry.
“When three critical issues faced our company— lack of accurate financial information, lack of good inventory records, and less than desirable customer service levels— we looked at Infor” . . . “it offered the flexibility and robustness we needed to create a closed-loop system. An FDA requirement is that we have full traceability, and Infor provides a method for tracking the expiration date on all raw materials.” -Dan Yahle, Senior Director of Materials Management, Meridian Bioscience.
With SyteLine Medical Device ERP, your company can track the movement of materials and parts from receipt to shipping and ensure products meet or exceed the standards required by customers and by regulatory agencies. Using 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 SyteLine’s integrated quality management system helps you easily collect, control, and analyze product data.
“We’ve reduced our scrap rate by 90%, and our accounting close cycle dropped from 8 days to 3 days.” —Kevin Powell, Director and US Controller, Meridian Bioscience. “Although our sales have doubled,” notes Powell, “our inventory has increased only very slightly. Infor has enabled us to increase our inventory accuracy from 60% to 99.9%.”
Medical device manufacturers must also bring innovative, new products to market rapidly to stay ahead of the competition. This requires moving product through design and prototyping phases and regulatory approval process to manufacturing production and quality control. SyteLine’s Product Lifecycle Management (PLM) capabilities assist 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.
Infor SyteLine Medical Device ERP 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
“It was being used in other medical device manufacturing companies— a big plus for us— and we wanted to partner with a company that was going to continue to improve the product, which we believed Infor would do.” -Dan Yahle, Senior Director of Materials Management, Meridian Bioscience.
Infor is a leading provider of business software and services, helping over 70,000 customers in 175 countries improve operations and drive growth. Infor customers include:
10 of the top 10 pharmaceutical companies
19 of the top 20 U.S. hospitals
12 of the top 13 high tech companies
19 of the top 20 aerospace companies
43 of the top 50 industrial distributors