Critical decision: Omnify sees PLM uptake in highly regulated med device industry


Omnify Software reports an increase in medical device manufacturers implementing product life-cycle management (PLM) technology due to the ability of Omnify’s solutions to support controlled design processes and manage data for FDA (Food and Drug Administration) compliance.
Omnify's growing medical device customer base includes companies such as Criticare Systems , a designer and manufacturer of patient monitoring technology; Pacific Biosciences , a developer of third-generation DNA sequencing technology; PLC Medical Systems , a medical technology company specializing in innovative technologies for the cardiac and vascular markets; Still River Systems , a developer of proton beam radiation therapy (PBRT) systems; and Thermage , a leader in non-invasive tissue tightening.
Many are leveraging Omnify Empower PLM to meet requirements set forth by the FDA regulation Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) and the FDA 21 CFR Part 820 Quality System regulation; and have completed the Software Validation process mandated by the FDA for software used to design, develop, or manufacture medical devices.
“The benefits medical device customers receive from our PLM solution is twofold,” says Chuck Cimalore, Omnify CTO. “First, they are able to benefit from improved product design and development processes. Second, they are able to leverage features such as history tracking, secure electronic signatures, reporting, a closed-loop Corrective and Preventive Action system, and training records management to meet stringent FDA compliance guidelines.”
“PLC’s validation of Omnify Empower confirmed that we chose wisely in selecting a PLM product,” says Ern Damon, document control manager for PLC Medical Systems. “Quality, Purchasing and Manufacturing have easily adopted the FDA 21 CFR Part 11 compliant electronic signature process and are capitalizing on both the workflow driven change process and the speedy distribution of approved changes.”

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