CIMdata PLM Industry Summary Online Archive

21 August 2012

Implementation Investments

Vessix Vascular Selects Product Lifecycle Management Solution from Omnify Software

Omnify Software today announces its latest Omnify Empower PLM implementation case study featuring a new medical device company, Vessix Vascular. Vessix Vascular is a privately-held, venture-backed, company that offers a unique approach to treating uncontrolled hypertension that is faster, easier to use and less painful for patients than any renal denervation system currently available in the market.

Vessix Vascular is comprised of a group of individuals with previous experience at successful medical device companies and one of their first priorities was to formalize their product design and development processes with PLM software. They wanted to implement PLM early on as a best practice for managing Bill of Materials (BOMs), engineering changes, product documentation, training records, and Corrective and Preventive Actions (CAPAs).

"Implementing a solution early on prevents the company from being bogged down by legacy data and processes when transitioning to an automated system in the future and also helps to eliminate resistance to change from employees entrenched in those practices," stated Rinda Sama, Vice President of Operations and Quality for Vessix Vascular. "Tools like Omnify Empower PLM that are affordable, already configured to meet the needs of medical device manufacturers and can adapt to a company's processes make it easy to adopt PLM as a start-up and get off on the right foot."

Vessix Vascular has already been through two ISO 13485 Quality System audits using the Omnify Empower PLM system. Prior to Empower PLM, Vessix would have to find and print documents to pull for an audit. Now, they can quickly search in Empower PLM to show the necessary documents along with change history, who approved the change, when it was released, change justifications, and links to any other Omnify Empower items relevant to that part.

"As the value of PLM software has become increasingly apparent among smaller manufacturers, we have seen more and more start-up companies -- particularly medical device manufacturers with their compliance mandates -- turning to Omnify Software for their PLM needs," stated Jack Rowntree, Chief Operating Officer for Omnify Software. "We make enterprise PLM accessible to the start-up market by delivering an easy-to-use, scalable system with the functionality these companies need to properly manage their product and compliance data."

For the complete case study visit: http://www.omnifysoft.com/Customers/Success.aspx?customer=25

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