Regulatory tools
Free databases, lookups, classifiers, and workpapers for recurring regulatory tasks.
Articles tagged Regulatory tools
7 articlesMedical Device IFU Translation: PDF Workflow and Review Checklist
Translate an IFU PDF with Pure Global, then review warnings, units, terminology, and layout using a practical checklist for medical device translation drafts.
Medical Device Letter of Authorization: Template and DOCX Guide
Create a medical device letter of authorization draft with Pure Global. Use the source brief, sample template, and review checklist before downloading DOCX.
FDA Medical Device Product Code Lookup: Find Class, Regulation, and Pathway
Search FDA medical device product codes for device class, regulation number, submission type, and related market evidence without starting in a generic chatbot.
Free CER Literature Search Tool: Build a Traceable Evidence Workpaper
Find candidate clinical evidence, preserve the exact search, and compose source-linked screening, study, outcome, appraisal, claim, and gap tables for CER work.
Free Medical Device Classification Tool: Compare Risk Class Across Markets
Run one structured product description through country-specific classification research, compare the applicable rules, and keep each result tied to its market context.
How to Search the FDA MAUDE Database for Medical Device Adverse Events
Use a free MAUDE search to find adverse event reports by product, manufacturer, or product code, then connect them to recalls and other FDA records.
Medical Device Registration Database Search: Find Products, Companies, and Competitors
Use one free global search to find public medical device registrations, verify manufacturers and holders, and continue into company or competitor research.
