Unlock medtech innovation with breakthrough AI agents
Our generative AI agents automate key approval & maintenance processes so you can focus on getting innovation to market
Focus areas
Regulatory
Approval strategy
Submission preparation
Post-market surveillance
Quality
QMS design
Change management
Audit prep
Reimbursement
Coding identification
Coverage & Payment review
Submission preparation
Benefit from agentic AI that is tailor-made for your processes
What leaders say...
Co-Founder, Health Sage AI
“We experience a lack of solutions to enable small and innovative teams to get regulatory approval. A solution like Guideways would be an instant buy for us to accelerate our product portfolio.”
Head of Regulatory, Surgical division, Baxter
“New regulations are coming out all the time across the USA, EU, China and emerging markets. There is a need for solutions like Guideways to enable my team to focus on the strategic issues and value add rather than being bogged down by tedious gap assessments”
Regulatory consultant, True North Consulting
“Obtaining and maintaining approvals involves many time-consuming and repetitive tasks such as gap analysis, predicate device analysis, and post-market surveillance. Guideways could automate these tasks, saving valuable time and resources to focus on activities that require our specialized expertise.”
