Medical Device start up company uses InfoStrength Smart Enterprise Suite to get ready for ISO 13485 and FDA 510k
September 24, 2007 - Durham, NC - CivaTech Oncology, Inc. uses InfoStrength's Smart Enterprise Suite to establish policies for regulatory, quality and corporate documents in preparation of ISO 13485 and FDA 510k.
"When you are starting a medical device company you need to watch where you spend time and money. CivaTech Oncology did not need to be spending money on servers, back-up devices and individual software applications that capture only certain aspects of the business," said Claudia Black, VP of Business Development. "I wanted to have all the regulatory, quality, corporate documents and collaboration in one place without building an expensive infrastructure. InfoStrength's Smart Enterprise Suite was a no brainier: with InfoStrength SES we have everything we need in one place to get ready to file for our ISO 13485 and FDA 510K. InfoStrength's ASP Hosted Solution also solved our risk management issue by managing our documents and backups at a secure offsite location."
About CivaTech Oncology, Inc.
The product focus is on low-dose-rate brachytherapy, a type of radiation treatment for cancer utilizing implanted radioactive sources to kill tumor cells. At present, this type of brachytherapy is used predominantly for prostate cancer and makes use of so-called "seeds," which are implanted in a minimally invasive surgical procedure. CivaTech Oncology's new device is more akin to a "radioactive string" that will replace the individual seeds and should provide more uniform and consistent radiation delivery to patients.
CivaTech Oncology Inc. Contact:
Claudia A. Black cblack@civatechonology.com
http://www.civatechoncology.com
About InfoStrength
InfoStrength®, Inc., exclusively serving biotechnology, pharmaceutical and medical device companies with internationally recognized regulatory expertise, developed InfoStrength® Smart Enterprise Suite (SES) with an innovative software development methodology specifically created for FDA regulated environments. InfoStrength SES is a configurable, modular, web-based application solution specifically designed to address business and regulatory initiatives of life science companies. InfoStrength® SES enables sharing critical information while ensuring management control, milestone accountability and market differentiating collaboration. The InfoStrength® solution delivers document, project and process management along with regulatory compliance controls and a robust validation package.
Infostrength Contact:
Richard Novacek, (919) 313-3965, dnovacek@infostrength.com
http://www.infostrength.com
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