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Guideways’ AI agents gives medtech teams instant, expert-level, structured and traceable answers to classification, pathways, standards and submission readiness.

What Guideways can do for you:

• Optimize your approval strategy from the start with underpinned classification, predicates and pathways.
• Earlier and comprehensive insight into approval requirements enables more reliable planning and fewer late surprises.
• Always available submission readynesss gap analysis allows teams to progress at fast pace without constant reliance on scarce expertise

Using FDA Sherpa helped us quickly define our intended use and map out the right FDA pathway for our next general vascular surgery robot

Saskia ten Siethoff
QA/RA Specialist, Flux Robotics