Seapine Software Helps Curb Compliance Worries for Medical Device Companies

MASON, Ohio—July 25, 2006—Time to market is critical in the medical devices manufacturing industry, and delays resulting from compliance audits can be extremely costly. Seapine Software, a leading provider of application lifecycle management and process management solutions, today announced it is actively addressing these issues with its suite of compliance requirements solutions for the medical devices sector. This solutions suite enables medical device companies to alleviate the pain of costly regulatory audits through the use of asset tracking, audit trail logging, and electronic signatures. These tools are particularly effective for companies in the medical devices sector, because they typically have very little or no tracking and accountability systems in place. Several medical device companies have recently chosen Seapine’s solutions to strengthen and automate development and ensure accountability and traceability. These include:

  • Medeikon Corporation
  • Kitware, Inc.
  • Topcon Medical Systems, Inc.

We have been delighted to find, in Seapine Software, an established provider of Configuration Management tools that understands the needs of the medical device industry,” said Dr. Rajeev Rohatgi, Director of Software Development, Medeikon. “The good people at Seapine have been very easy to work with.”

Seapine's suite of solutions include TestTrack Pro, an issue management solution that provides issue tracking and includes a configurable workflow, Surround SCM, a version control solution that tracks changes and keeps documents, source code, and other digital assets organized, and Seapine CM, a complete change management solution that brings together comprehensive configuration management and flexible issue tracking.

Seapine Software has provided these solutions to the medical devices sector for nearly five years. Customers include Kodak Medical Imaging, Philips Medical Systems, Thermo Electron Corporation, Medtronics MiniMed, and SRU Biosystems, Inc.

"Over the past several years, our suite’s adaptable workflow has been helping medical device companies implement and manage business processes that meet regulatory standards, saving them both time and money,” said Richard Riccetti, president and CEO, Seapine Software. “We’re excited to have these companies on board with Seapine, and we look forward to assisting additional medical device companies in the future."

About Seapine Software
Seapine Software, Inc. is a privately held technology company whose application lifecycle management (ALM) solutions help companies manage the process of developing high-quality complex products—often in regulated industries. Our award-winning ALM solutions drive the creation of recognized brands, life-saving medical devices, even games of the year.

Founded in 1995, Seapine has headquarters in Cincinnati, Ohio, and offices in Europe, Asia-Pacific, and Africa with over 8,500 customers worldwide. For more information, visit www.seapine.com.

Media Contact:
Sarah Carefoot
Director, Corporate Communications
(513) 754-1655
carefoots@seapine.com

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