EVENT HIGHLIGHT – Realize LIVE Special Session on Streamlining CSV with the FDA

By Claudia Basso

Join us at a special session of Realize LIVE to learn how to reduce costs and simplify the task of documenting Computer Software Verification (CSV).

In this session, you will learn about several streamlined approaches supported by the FDA and hear how Zoll LifeVest (maker of wearable cardioverter defibrillators) has been able to drive 60%+ reduction in labor hours and 80%+ reduction in process validation time by applying a true risk-based approach on CSV to applications like Camstar MES.

Zoll LifeVest’s success comes at a critical time for the medical device and diagnostic (MD&D) industry, in light of the FDA’s upcoming draft guidance, “Computer Software Assurance for Manufacturing and Quality Software.” Working together with Siemens, the FDA and other MD&D manufacturers, Zoll has been collaborating to significantly streamline and reduce the CSV documentation burden for the industry.

The goal of this session is to inspire you to:

  • Realize faster time to value

  • Reduce total cost of ownership

Zoll manager of quality assurance Frank Meledandri Sr. and Siemens PLM Software senior director of strategic initiatives/customers Jason Spiegler will present this session. With seats filling quickly, we encourage our Camstar community to attend. [LINK]

Realize LIVE, the industry’s largest gathering of Siemens Digital Industries software professionals in a single forum, is taking place June 10-13, 2019 at the Cobo Center, Detroit, Michigan, U.S.

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This article first appeared on the Siemens Digital Industries Software blog at