TechExcel DevSuite Facilitates IEC 62304 and FDA 21 CFR Part 11 Regulatory Compliance for Medical Device Manufacturers
LAFAYETTE, CALIF. – May 20, 2013 – TechExcel Inc., a leading provider of Application Lifecycle Management (ALM) solutions, today announced availability of TechExcel DevSuite for Medical Device Software Development, an industry-proven lifecycle management solution that helps medical device manufacturers bring products to market faster and ensures development processes are complaint with global regulations including FDA 21 CFR Part 11 and IEC 62304.
Streamlining development processes while verifying software quality and complying with strict regulatory requirements is a challenge for medical device companies. TechExcel helps overcome these challenges with a comprehensive lifecycle management solution that provides end-to-end quality test management; complete traceability and visibility; and supports distributed and multiple methodology development.
TechExcel DevSuite is an integrated platform for project planning, issue tracking, task tracking, and quality management that ensures software is produced consistently and efficiently across the entire software development lifecycle. TechExcel DevSuite for Medical Device Software Development is a preconfigured system with integrated best practices for achieving and demonstrating compliance with FDA guidelines and medical device industry standards for software development. System features include:
- Built-in configurable templates for FDA and IEC compliance
- Out-of-the-box support for FDA General Principles for Software Validation
- End-to-end software defect prevention, verification and validation
- Full traceability for all artifacts through the entire SDLC
- Complete transparency with on-demand reporting and traceability metrics