Drive innovation and achieve regulatory compliance
As medical devices companies face increased product complexity, time to market and competitive challenges, and increasingly strict regulatory standards for quality and patient safety, IBM 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
IEC 62304 compliance
Best practices for medical device software development
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.
- Webcast: Meeting your FDA design control needs with requirements and change management
- Webcast: Improving healthcare through standards and interoperability
- Solution brief: Improve processes, manage IEC 61508 and IEC 62304 standards, develop quality products (PDF, 726KB)
- White Paper: Challenges and opportunities for the medical device industry
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Challenges and opportunities for the medical device industry
A deep dive into IEC 62304 to identify key steps, best practices, and best of breed integrated tooling to help companies conform to IEC 62304 on the way to FDA and international approval of their medical device.
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Marty Bakal, WW Offering Manager, Electronics Industry
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Bruce Douglass, Rational Chief Evangelist
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Customer story: Diagnostic Grifols
With IBM Rational, Diagnostic Grifols reduced time to market and aided regulatory compliance.
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Safety critical software
Ensuring standards compliance for medical device software