by admin | Jan 13, 2026 | News
By Alexander Habermeier Early access to the Guideways platform for medtech innovators Regulatory and compliance complexity remains one of the biggest barriers to bringing medical innovation to patients. While science and technology continue to move fast, regulatory...
by admin | Jan 12, 2026 | Blog
Compliance vs. regulatory intent In highly regulated industries, there is a temptation to treat FDA guidance as a checklist. However, experienced reviewers know that regulatory intent matters more than rote compliance. The FDA’s guidance on clinical decision support...
by admin | Jan 7, 2026 | Blog
Most regulatory problems are locked in early Medical device executives often focus on the moment of submission, yet many delays stem from decisions made months or years earlier. The FDA’s average 510(k) submission now exceeds 1.000 pages, even though it is the...
by admin | Jan 2, 2026 | Blog
Why the AI hype has not solved regulatory navigation yet Large‑language models and other foundation models have made it possible to search and summarise FDA guidance at unprecedented speed. However, subject matter experts note that they do not automatically translate...
by admin | Nov 10, 2025 | News
Dutch startup accelerates approval process for medical innovations with AI platform Utrecht, The Netherlands, 10 November 2025 – Guideways, the AI company helping medtech innovators navigate complex regulatory and approval processes, has raised pre-seed funding from...
