Pure Global

Pure Global, presented on its website as a medical device regulatory consulting firm, provides market access and regulatory compliance solutions for medical devices, in vitro diagnostics (IVDs), and software as a medical device (SaMD). The page describes services including global medical device registration across 30+ markets, in-country representation, quality management system consulting for ISO 13485, FDA QMSR and MDSAP, risk-based supplier audits, and medical device cybersecurity support. It also lists free databases and AI tools covering device registrations, clinical trials, regulations, timelines, government fees, and regulatory workpapers. The website states pricing is a market-specific flat annual fee that varies by country, device class, and portfolio size and excludes government fees, and offers a Fee Calculator for estimates. The site describes support for startups, scaleups, and multinational enterprises, and states it has offices in 15+ countries and has served 500+ clients with 2500+ registration certificates.

Key features

• Global medical device registration consulting for devices, IVDs, and SaMD across 30+ markets
• In-country representation for medical device, IVD, and SaMD manufacturers
• Quality management system consulting for ISO 13485, FDA QMSR, and MDSAP readiness and remediation
• Risk-based medical device supplier audits
• Medical device cybersecurity support covering FDA, EU MDR, and IEC 81001-5-1
• AI-powered dossier compilation
• Free databases and AI tools for device registrations, clinical trials, regulations, timelines, and government fees
• Fee Calculator for instant pricing estimates
• Regulatory news, blog, and AI-powered regulatory update tool

Best suited for

• Medical device manufacturers seeking market access in multiple countries
• IVD and SaMD manufacturers needing in-country representation
• Medtech startups, scaleups, and multinational enterprises
• Manufacturers needing ISO 13485, FDA QMSR, or MDSAP quality system support
• Companies needing medical device cybersecurity regulatory support

Pricing

Pricing is a market-specific flat annual fee that varies by country, device class, and portfolio size, excludes government fees, and includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support. A Fee Calculator is available for instant estimates.