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Customer Success Stories

Omnify Empower PLM has been recognized by G2 Crowd, the world's leading business software review platform, as a high performer earning the highest overall satisfaction score in the Winter 2016 PLM Software Grid report.
Below is a sampling of our many customer success stories.
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Axonics Modulation Technologies
Establishing Design Controls with Omnify Empower Helps Axonics Receive CE Mark for Sacral Neuromodulation
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Establishing Design Controls with Omnify Empower Helps Axonics Receive CE Mark for Sacral Neuromodulation
The team at Axonics had previous experience with Product Lifecycle Management (PLM) at another medical device start-up. They knew the benefits that an electronic, online PLM solution could provide a small to medium-sized medical device company.
One particular area where Axonics saw the greatest benefit of a PLM solution was with electronic sign-offs. With paper-based processes and insufficient signatories, approvals are serial in nature and the absence of a key approver can translate into a major delay. Axonics wanted to prevent this issue with an automated system that offered the ability for Axonics staff to continue the approval process for documents/drawings/training/etc., on or off-site, via remote logins and allow for the assignment of signatories.
Axonics wanted a software solution that would facilitate Active Implantable Medical Device (AIMD) product development under a Quality System compliant to ISO 13485 and the FDA CFR (Code of Federal Regulations), as well as other regulatory frameworks.
"We were told by industry experts that a new Sacral Neuromodulation product would take five years to receive CE marking, but we accomplished that milestone in just two years after initiating design controls with Omnify Empower. Omnify facilitates rapid design, document, and BOM controls in tandem with supplier approvals and vendor item linkages. All these aspects and more allow us to achieve our ambitious timelines."
-Joseluis Espinosa, Director, Quality Engineering , Axonics Modulation Technologies
Key benefits:
  • Flexible and configurable system for growing medical device company
  • Fully implemented in only a few weeks
  • Able to receive CE marking in just two years compared to industry average of five years
  • Met goal of having an automated system for electronic sign-off with signatories
  • ISO 13485 and FDA CFR-compliant Quality System
  • Established Design Controls