Infor SyteLine ERP for Medical Device Manufacturers
Medical device manufacturing has very little tolerance for error—and quality is of high importance. If your products don’t deliver what you promise, lives can literally be at stake. At the same time, product returns erode your profit margins, while customer satisfaction can make or break your reputation. For companies with unique patented products, meeting demand puts added pressure on every stage of your supply chain.
With Infor SyteLine ERP™ Industrial ERP for Medical Devices, you can access context-specific data on a broad variety of devices and collaborate across your engineering, manufacturing, operations, sales, customer service, and quality support teams. You’ll be able to react to spikes in demand; ensure you have the right materials available to meet projected demand; communicate known product quality issues across your teams; and access best practices.
Adhering to regulations is not optional. Here are a few of the FDA quality regulatory programs to comply with:
- 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.
Learn more about how Godlan and Infor SyteLine ERP for Medical Device Manufacturers can help you become an industry leader and ensure the opportunity for a profitable future. Use the form below to contact us: