Company intelligence
Pure Global
Unlocking Global Markets For MedTech Companies, combining real-world experience with AI and data.
About Pure Global
Pure Global unlocks global markets for medtech companies. We combine real-world experience with AI and data to build smart, efficient medical device regulatory consulting solutions for more than 30 markets. Accelerate market entry with AI-powered dossier compilation and local regulatory representation, all for a flat annual fee. Use the Fee Calculator on our website to get your instant estimate with a few clicks.
Verified activity
Signals from Pure Global
6 published signals
Legal & Regulatory
Pure Global published two FDA QMSR Warning Letters testing connections between records, including ISO 13485:2016 clauses and risk-management findings.
Reported by Pure Global
Legal & Regulatory
Pure Global notes that MDCG 2026-4 turns the EUDAMED SSCP and SSP transition into a record-level handoff.
Reported by Pure Global
Legal & Regulatory
Pure Global notes that INVIMA Clarifies When Wearables Are Medical Devices in Colombia, providing important clarification on when smartwatches, bracelets, rings, or other wearables become medical devices in Colombia based on manufacturer's intended purpose.
Reported by Pure Global
Products & Services
Pure Global published a new newsletter featuring regulatory developments, new resources, and opportunities to support global market access strategy.
Reported by Pure Global
Legal & Regulatory
Pure Global notes that the HSA GN-21 Revision 7 requires HSA approval for 6Aii and 6Aiii changes to public SMDR listing particulars.
Reported by Pure Global
Legal & Regulatory
Pure Global notes that each SMDR listing can have no more than two active change-notification applications.
Reported by Pure Global