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Axonics Modulation Technologies Adopts Omnify Software to Establish Design Controls

Omnify Empower PLM Helps Axonics Receive CE Mark for Sacral Neuromodulation Product in Record Time
Tewksbury, MA, October 10, 2017
Omnify Software, a leading provider of web-based Product Lifecycle Management (PLM) software for discrete manufacturers, today announces that Axonics Modulation Technologies, Inc., a privately-held medical device company developing an innovative neuromodulation platform based on miniaturized rechargeable technology, has implemented the Empower PLM system to establish design controls for regulatory compliance.
Axonics wanted a software solution that would facilitate Active Implantable Medical Device (AIMD) product development under a Quality System compliant to ISO (International Organization for Standardization) 13485 and the FDA CFR (Code of Federal Regulations), as well as other regulatory frameworks. They selected Omnify Empower PLM because it offers a flexible and configurable system for small medical device companies. Implementation of Omnify Empower took only a few weeks and an ISO 13485-compliant Quality System was established within five months of the first DCO (Document Change Order) release. Axonics currently utilizes the Document Control, Bill of Material (BOM) management, Supplier Management, Training Management, and Equipment Management modules. They have also configured Omnify Empower to address areas such as: material citations, calibration and preventive maintenance, component characteristics, and Design History File (DHF) auto-generation.
“Omnify facilitates rapid design, document, and BOM controls in tandem with supplier approvals and vendor item linkages, allowing us to meet our ambitious timelines,” stated Joseluis Espinosa, Director, Quality Engineering for Axonics Modulation Technologies. “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.”
“For growing medical device companies like Axonics that are bringing new products to market and are required to meet regulatory guidelines, depending on paper processes to manage product and compliance information could be detrimental to their business,” stated Chuck Cimalore, CTO for Omnify Software. “Our medical device customers adopt Empower PLM in order to gain an electronic, configurable system to establish design controls and to be able to prove out their processes for regulatory requirements.”
About Omnify Software
Omnify Software, the leading provider of business-ready Product Lifecycle Management (PLM) solutions for discrete manufacturers, helps OEMs shorten development cycles, accelerate product innovation and improve bottom-line profitability. Omnify's commitment to customer success has resulted in a unique solution that is quick to implement, easy to use, and provides an open integration platform. Our web-based solution offers flexible deployment options that allow customers to deploy on-premises, hosted or in the cloud. Omnify is well-known for superior customer service, delivering outstanding training, development and support with a team of experienced technology professionals. For more information about Omnify Software Product Lifecycle Management, please call 978-988-3800, email, visit, LinkedIn, Twitter and YouTube.
"Omnify" is a registered trademark of Omnify Software. Any trade, product or service name referenced in this document using the name "Omnify" is a trademark and/or property of Omnify Software. All other trade, product, or service names referenced in this release may be trademarks or registered trademarks of their respective holders.