Agile Software has released a version of its product lifecycle management software aimed at manufacturers of medical...
The AgileMD PLM software will allow the companies to track and manage product-related information from the research and development stage throughout the entire lifecycle in accordance with US Food and Drug Administration requirements.
"Medical device manufactures have to support new government regulations that require electronic data management, access control, audit trails and electronic signatures," said IDC analyst Gisela Wilson.
AgileMD offers companies the ability to track products from the development stage through clinical trials, regulatory approval, commercial introduction and, ultimately, phase-out, said Marcus Yoder, director of Agile's life sciences business.
The software also includes so-called validation protocol packs designed to prove that the software works, among other things, in compliance with the FDA's overall requirements for Corrective Action/Preventative Action management for the medical device industry, according to Yoder.
Forrester Research has predicted that small and medium-sized companies in the US will increase their PLM spend more than tenfold, from $62m in 2003 to $704m in 2008.
Jaikumar Vijayan writes for Computerworld