TechExcel DevSuite Facilitates IEC 62304 and FDA 21 CFR Part 11 Regulatory Compliance for Medical Device Manufacturers

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Industry-Proven Lifecycle Management Solution Enables Easy Compliance with Global Regulations, While Streamlining Development Processes for Improved Product Quality and Faster Time-To-Market

Companies worldwide rely on TechExcel to assist them with incorporating best practices throughout the development lifecycle and fully comply with regulatory standards.

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

“The toughest challenge facing medical device manufacturers is juggling increased regulatory scrutiny and time-to-market pressures,” said Dr. Tieren Zhou, TechExcel Founder and Chief Software Architect. “TechExcel DevSuite for Medical Device Software Development provides these organizations with a proven solution for streamlining workflow; increasing productivity and collaboration across multi-site development, operations and administration teams; and is tailored specifically to help incorporate sustainable processes that ensure continuous regulatory compliance.”

Companies worldwide rely on TechExcel to assist them with incorporating best practices throughout the development lifecycle and fully comply with regulatory standards, including industry leader Haemonetics Corporation. Organizations using TechExcel DevSuite integrate requirement management and task management with test case management, defect prevention and end-to-end software verification and validation. Additional information on TechExcel DevSuite for Medial Device Software Development is available on the company’s website at http://techexcel.com/solutions/medical-device-development/.

About TechExcel
TechExcel is a privately held software company dedicated to developing intelligent software solutions to optimize today's business processes. A leading provider of integrated IT service management, customer support and application lifecycle management solutions, TechExcel seamlessly integrates Web, wireless, and client/server technologies to provide companies with the power and flexibility needed to better manage their business.

Founded in 1995 and headquartered in Lafayette, California, TechExcel maintains over 1,500 customers in 43 countries and regions in the world, including 20% of global top 500 enterprises. For more information, visit http://www.techexcel.com.

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Scot Howard
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