Free Tools
Free tools that speed up your everyday regulatory work. No sign-up; your data stays in your browser.
FDA pre-classification tool
Three questions to see your device’s likely FDA class (I, II, III) and premarket pathway: 510(k) exempt, 510(k), De Novo or PMA.
LiveMDR classification tool
Find your preliminary class, the rules applied and your conformity route under the 22 rules of Annex VIII.
LiveMDR transition deadline calculator
See whether 2027 or 2028 applies to your device under Regulation (EU) 2023/607, how many days are left, and a backward plan.
LiveGSPR checklist builder
Filter the 23 requirements of MDR Annex I for your device, map standards and evidence, and export to Excel or Word.
LiveISO 14971 risk matrix & register
Set up your acceptability matrix, score hazards before and after risk control and export your risk register.
LiveCAPA & nonconformance templates
Fillable forms structured around ISO 13485 clauses 8.3 and 8.5, with 5-Whys analysis; download as Word.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.