ANDOVER, Mass.--Omnify Software (www.omnifysoft.com) recently announced that medical device customers are using the Omnify Empower PLM software to automate product development and training processes for Food and Drug Administration (FDA) and International Standards Organization (ISO) compliance. According to the company, Omnify Empower PLM provides medical device manufacturers with key benefits that include training management functionality and a single location to track and manage all product data through an automated process.
Procedures and product training are constantly changing, particularly with medical devices. In addition, companies that need to meet FDA or ISO regulations are required to implement and document employee training. Omnify says that incorporating Training Management within its system eliminates the need for customers to purchase and manage a separate training solution; it also associates training events with all product and project data stored in the Omnify database. According to the software developer, users of Omnify Empower PLM are able to have training as part of the engineering change process to easily track product and procedure revisions, automatically configure new training requirements, and generate new training alerts for affected personnel. This ensures that all appropriate parties are notified and guarantees that training requirements are fulfilled, the company says.
One of the companies using Omnify Empower PLM to manage product development and training processes and meet compliance is PLC Medical Systems, Inc. (Franklin, Mass.), a company focused on innovative cardiac and vascular medical device-based technologies. “In our most recent ISO compliance audit, Omnify Empower was noted as a significant enhancement and a demonstration of our commitment to continuous improvement,” stated Jeff Steward, director of IT for PLC Medical Systems, Inc. “Having our training process automated and managed in Omnify helps to determine if people were actually trained and lets us know who was notified, when, and on what, which is very important for us or anyone looking to be FDA or ISO compliant.”
“Omnify” is a registered trademark of Omnify Software.
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