Medical device manufacturers are subject to many government regulations to protect the public. FDA rules frequently change to keep up with new technology and its challenges.
While these regulations are designed to ensure the safety of those involved, they make staying in compliance difficult.
Fortunately, a medical device ERP system helps keep manufacturers up-to-date with compliance issues and improves overall productivity. The right medical device software is vital to success and longevity in this industry.
Common Challenges in an FDA-Regulated Environment
When dealing with the FDA, gaining approval for medical devices is only the first step. FDA-Regulated Environmental oversight is a very involved process with many factors in play. The agency continues to monitor the manufacture of these devices and has the power to recall them if it finds something wrong such as a decline in quality, mislabeling, toxic ingredients, etc.
The FDA has three categories for medical devices: Class I, Class II, and Class III. Class III devices are exposed to the highest level of FDA regulatory control. The standard safety monitoring requirements for manufacturers from the FDA include the following:
ESTABLISHMENT REGISTRATION
Foreign and domestic manufacturers must electronically register their establishments with the FDA unless they have a signed waiver.
MEDICAL DEVICE LISTING
Manufacturing establishments must list all their devices with the FDA, including contract manufacturers, re-packagers and re-labelers, specification developers, etc.
PREMARKET NOTIFICATION 510(K)
If the device requires this notification, manufacturers cannot distribute it until you receive an authorization letter from the FDA.
INVESTIGATIONAL DEVICE EXEMPTION (IDE) FOR CLINICAL STUDIES
An IDE allows an “investigational device” to be used in a clinical study.
LABELING REQUIREMENTS
These regulations pertain to the labels on the device and the literature that comes with the device.
MEDICAL DEVICE REPORTING (MDR)
Manufacturers must report any incident with a device that “caused or contributed to a death or serious injury.” These reports are filed through the Medical Device Reporting program. Due to how specific some malfunctions can be, it’s crucial that you file a statement as well so you aren’t held liable.
It’s no secret that dealing with the FDA’s requirements isn’t exactly a thrilling process, and that’s if everything is going smoothly. If you encounter any problems, the process becomes more unwieldy and demanding. A medical device ERP system is necessary to streamline operations and improve regulatory compliance.
The Benefits of a Medical Device ERP System in an FDA-Regulated Environment
A medical device ERP such as Netsuite for Life Sciences was designed to help take the stress out of working within an FDA-regulated environment. This software system provides the following advantages:
Cloud Access
Cloud computing gives you the flexibility to work from anywhere, reduces administrative hours, provides automation for many tasks, and keeps the software up-to-date.
Audit Trails
A medical device ERP tracks all financial transactions making it simple to verify your accounting in case of an audit.
Automation
Your ERP system will automate many repetitive and monotonous tasks that take hours of manual processing, saving you time and money while increasing productivity.
Traceability
NetSuite ERP for Life Sciences offers you the traceability that the FDA requires. This system allows you to closely monitor your supply chain, allowing you to trace the weak links and phase them out to prevent dangerous or defective devices harming the public.
Medical Device ERP System Requirements
You have plenty of options when selecting medical device ERP systems, but your software should meet the following requirements to manage your organization’s needs effectively:
Optimized Supply Chain
This feature gives you real-time inventory visibility and enhances communication with all stakeholders, regardless of location.
Streamline Sales Cycles
Your ERP should provide a 360-degree view of the client across all channels so you can anticipate seasonal fluctuations that affect your company. This feature gives you excellent inventory control.
Unified Platform
You need a medical device ERP that can merge multiple systems and data sources into one software solution. When data runs through one centralized location, your reaction times to unexpected challenges increases, reducing stress.
360-Degree Customer View
Your medical device ERP should provide customized real-time reporting on every customer interaction simply and efficiently.
These ERP features lower costs, increase productivity, and enhance compliance.
How GBS Can Help
At Green Business Systems, we offer NetSuite EPR for Life Sciences, the software system designed from the ground up to meet all your medical device company’s necessary requirements. Our experienced consultants can customize and integrate this software to make staying FDA-compliant much easier and less time-consuming. You will save countless employee hours and should significantly reduce your overhead costs.
At GBS, our goal is to provide exceptional customer support. We understand compliance issues and will deliver a fast, accurate response to your inquiries.
We never keep you waiting for a response for more than two hours. As a medical device manufacturer, you are under pressure to serve the public while managing your business needs. At Green Business Systems, we make you a priority, helping you during every stage of your compliance journey.
Take Control of Your Compliance Demands
The struggle to comply with every rule and safety regulation is a common issue in the medical device industry. The FDA works to protect the public interest, and that means constantly changing regulations. Staying current with these changes is difficult unless you have a medical device ERP system such as NetSuite for Life Sciences.
With NetSuite ERP, you will gain the flexibility, traceability, and automation necessary for your industry, while simultaneously complying with each FDA requirement. Contact Green Business Systems services today or fill out a brief online form. One of our experienced consultants will be happy to answer your questions about a medical device ERP system.
