Medical Device start up company uses InfoStrength Smart Enterprise Suite to get ready for ISO 13485 and FDA 510k

Released on: September 24, 2007, 8:22 am

Press Release Author: Richard Novacek

Industry: Pharmaceuticals

Press Release Summary: 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.


Press Release Body: 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.



Web Site: http://www.infostrength.com

Contact Details: Richard Novacek
InfoStrength Inc.
4220 NC Highway 55
Durham, NC 27713(919) 313-3965
dnovacek@infostrength.com http://www.infostrength.com

  • Printer Friendly Format
  • Back to previous page...
  • Back to home page...
  • Submit your press releases...
  •