ERP for Medical Device Manufacturers

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. 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 ERP for Medical Device Manufacturers is a comprehensive software solution that includes the manufacturing, inventory control, and quality assurance capabilities needed by companies to succeed in this industry. Infor SyteLine ERP helps you bring products to market more quickly, as well as track and manage after-market maintenance and service, while allowing you to manage FDA validation scripting, use electronic signatures, and comply with Title 21 CFR (Code of Federal Regulations).

Adhering to regulations is not optional. Here are a few of the FDA quality regulatory programs which require compliance:

• Case for Quality (CFQ)—The FDA’s Case for Quality regulations focus on data transparency.
• FDA CFR 21 Part 820—FDA CFR 21 Part 820 is a quality systems regulation the FDA uses to ensure that there are controls and documentation systems for a medical device’s entire product lifecycle—from design, engineering, and manufacturing, to shipment and after-sales service.
• Quality System Regulation (QSR)—The FDA developed Quality System Regulation (QSR) standards to regulate good manufacturing processes (GMP) for  medical device manufacturing.
• ISO9001, ISO9002, and ISO13485—ISO9001, ISO9002, and ISO13485 are standard quality regulations that medical device manufacturers must meet.
• EN46001—EN46001 is the European standard for medical device industries that all European medical devices must fulfill.
• 21 CFR Part 11—Because the pharmaceutical, healthcare, and medical device industries involve so many documents—and are under such high scrutiny from federal government agencies—21 CFR Part 11 has been put in place to help eliminate many physical records, while preserving the integrity of the electronic records for auditability. 21 CFR Part 11 helps companies demonstrate that electronic records are verified, controlled, and generally certified as audit worthy by means of electronic signatures.

More Customer Testimonials

With Infor SyteLine ERP, 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 ERP, 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 ERP’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 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 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.