As medical devices companies face increased product complexity, time to market and competitive challenges, and increasingly strict regulatory standards for quality and patient safety, Rational solutions for the medical devices industry can help.
IBM Rational provides an integrated, end-to-end traceable solution to help medical device companies that embed software in their devices:
- Improve their processes
- Automate FDA document generation
- Bring innovative, safe, high-quality products to market – differentiated through software
Facilitate compliance with medical device regulatory standards
As companies face increased product complexity, time to market and competitive challenges, and increasingly strict regulatory standards for quality and patient safety, Rational solutions for the medical devices industry can help you bring smarter products to market with an integrated solution across the product development lifecycle.
Learn more:
- Solution Brief: Improve processes, manage IEC 61508 and IEC 62304 standards, develop quality products
- White Paper: Challenges and opportunities for the medical device industry
- Webcast: Achieve compliance with IEC 62304 for medical device software development (link resides outside of ibm.com)
- Webcast: IEC 62304 for Medical Device Software Development (link resides outside of ibm.com)
- Webcast: Life cycle requirements for developing and maintaining software per IEC 62304 (link resides outside of ibm.com)
Where Rational products help you
- IBM Rational Focal Point™ for product portfolio management
- IBM Rational DOORS® for requirements engineering
- IBM Rational Rhapsody® for model driven systems engineering and embedded software development
- IBM Rational Team Concert™ for collaboration, workflow, and configuration management
- IBM Rational Quality Manager for test planning, execution, and tracking
- IBM Rational Publishing Engine for automated document generation
- IBM Rational AppScan® for static and dynamic security testing
