Omnify Software 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.”
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