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:
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.
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.
Marty Bakal, WW Offering Manager, Electronics Industry
Bruce Douglass, Rational Chief Evangelist
Learn more about Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA) for systems development
This podcast discusses the regulatory compliance considerations and the key product development lifecycle practices that are needed to build Smartphone-based medical devices.
With IBM Rational, Diagnostic Grifols reduced time to market and aided regulatory compliance.
Ensuring standards compliance for medical device software