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).

40+ Years of Exceptional Service for Manufactures

A Top Choice ERP Software For Top Medical Industry Enterprises.

Infor is a leading provider of business software and services, helping over 70,000 customers in 194 countries improve operations and drive growth.

Infor customers include:

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.

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
“We’ve reduced our scrap rate by 90%, and our accounting close cycle dropped from 8 days to 3 days. Although our sales have doubled, our inventory has increased only very slightly. Infor has enabled us to increase our inventory accuracy from 60% to 99.9%.“
Kevin Powell
Director and US Controller, Meridian Bioscience
Having the same system and accounting structures in different countries actually helps us cooperate and be more efficient in the way we work. We speak the same language.”
Madeleine Westberg
Director of IT Solutions Europe, ELEKTA
“Most importantly for our IT department, SyteLine supports Microsoft SQL Server. This means we are able to exploit a wider pool of talent for the ongoing support of the software and are much better positioned for the future.”
Donovan Naidoo
IT Manager, Blatchford

Key Features of SyteLine ERP for Medical Devices Manufacturing

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.

Significantly improve production and profitability:

Stay compliant with FDA quality regulatory programs:

1: Case for Quality (CFQ)

The FDA’s Case for Quality regulations focus on data transparency.

2: 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.

3: Quality System Regulation (QSR)

The FDA developed Quality System Regulation (QSR) standards to regulate good manufacturing processes (GMP) for  medical device manufacturing.

4: ISO9001, ISO9002, ISO13485 and EN46001

Standard quality regulations that medical device manufacturers must meet.

5: 21 CFR Part 11

21 CFR Part 11 helps companies demonstrate that electronic records are verified, controlled, and generally certified as audit worthy by means of electronic signatures.

Related Resources


Find more helpful resources inside the

Learning Center

Move Your Enterprise Forward.

Let’s unlock your full potential together. Reach out to our team today to begin a conversation to discuss your specific needs, infrastructure, and growth opportunities.

Godlan is a name you can trust.

Scroll to Top


Access everything in the learning center. 

Not a member? Don’t worry, it’s free…

Join once for free, get lifetime acess...

Hundreds of resources, trainings, white papers, demo videos, case studies, and more on the inside…

This field is for validation purposes and should be left unchanged.

Already have an account?