Omnify Software Helps Medical Device Customers Automate Training Processes

PLM Solution Supports Product Development and Compliance Needs in Single System.

ANDOVER, MA - Omnify Software, a leading provider of Product Lifecycle Management (PLM) software for electronic, medical, mechanical, and defense manufacturers, today announced that medical device customers are leveraging the Omnify Empower PLM solution to automate product development and training processes for Food and Drug Administration (FDA) and International Standards Organization (ISO) compliance.

In addition to providing a single location to track and manage all product data through an automated process, a key benefit of Omnify Empower PLM for medical device manufacturers is Omnify's training management functionality. Companies that need to meet FDA and/or ISO regulations are required to implement and document employee training. Incorporating Training Management within the Omnify system not only eliminates the need for customers to purchase and manage a separate training solution, it associates training events with all product and project data stored in the Omnify database.

Procedures and product training are constantly changing, particularly with medical devices. With Omnify, customers 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 all appropriate parties are notified and guarantees training requirements are fulfilled.

PLC Medical Systems, Inc., a company focused on innovative cardiac and vascular medical device-based technologies, is one of many customers meeting compliance by leveraging Omnify Empower PLM to manage product development and training processes. "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 Empower PLM provides medical device manufacturers with a solution that delivers the functionality to support their product development and compliance needs in one central location," stated Chuck Cimalore, CTO for Omnify Software. "Incorporating features such as a closed-loop Corrective and Preventive Action system and training records management into the PLM suite is the result of working closely with customers like PLC Medical Systems in order to provide a system that truly delivers complete product record management."