MedFortis Resources https://www.medfortis.org/blog/ Guides on regulatory intelligence for medical devices — FDA MAUDE, MHRA, Health Canada, EU MDR, PSUR reporting and grey-market surveillance. en MHRA Field Safety Notices & Medical Device Alerts: How to Monitor Them https://www.medfortis.org/blog/mhra-field-safety-notices https://www.medfortis.org/blog/mhra-field-safety-notices Fri, 24 Jul 2026 12:00:00 GMT What MHRA field safety notices and device alerts are, how they differ, where they're published, Yellow Card reporting, and how UK device manufacturers monitor them post-Brexit. openFDA Device Event API: How to Query FDA MAUDE Programmatically https://www.medfortis.org/blog/openfda-device-event-api https://www.medfortis.org/blog/openfda-device-event-api Fri, 24 Jul 2026 10:00:00 GMT A developer's guide to the openFDA device event API for querying FDA MAUDE — search syntax, counting, pagination, rate limits, API keys and the gotchas, with real working queries. How to Choose Post-Market Surveillance Software https://www.medfortis.org/blog/how-to-choose-post-market-surveillance-software https://www.medfortis.org/blog/how-to-choose-post-market-surveillance-software Tue, 21 Jul 2026 12:00:00 GMT Seven evaluation criteria, red flags to watch for, the questions that separate marketing from capability, and an evaluation checklist. What Is Regulatory Intelligence Software for Medical Devices? https://www.medfortis.org/blog/what-is-regulatory-intelligence-software https://www.medfortis.org/blog/what-is-regulatory-intelligence-software Tue, 21 Jul 2026 11:00:00 GMT What the category covers, the four jobs it does, how it differs from a QMS, who uses it, and the one-question test for any tool. Grey-Market Medical Devices: How Diversion Happens and How to Stop It https://www.medfortis.org/blog/grey-market-medical-devices https://www.medfortis.org/blog/grey-market-medical-devices Tue, 21 Jul 2026 10:00:00 GMT Why unauthorized resale listings are a safety and liability risk, how devices end up on eBay, DotMed and LabX, and the watchlist-to-takedown workflow that stops them. Beyond the FDA: Monitoring Global Medical Device Regulators https://www.medfortis.org/blog/beyond-fda-monitoring-global-regulators https://www.medfortis.org/blog/beyond-fda-monitoring-global-regulators Tue, 21 Jul 2026 09:00:00 GMT What MHRA, Health Canada, EU Safety Gate, Swissmedic and EUDAMED each publish, why signals surface in one jurisdiction first, and how to consolidate all six sources. How to Monitor FDA MAUDE for Adverse Events https://www.medfortis.org/blog/how-to-monitor-fda-maude https://www.medfortis.org/blog/how-to-monitor-fda-maude Wed, 01 Jul 2026 12:00:00 GMT How to access the FDA MAUDE adverse-event database (web search, openFDA API, bulk downloads), scope and run a repeatable monitoring workflow, and the limitations to respect. PSUR vs PMS Report: What's the Difference? https://www.medfortis.org/blog/psur-vs-pms-report https://www.medfortis.org/blog/psur-vs-pms-report Wed, 01 Jul 2026 11:00:00 GMT Which EU MDR device classes need a PSUR vs a PMS Report, what goes in each, how often to update them, and who reviews them. EU MDR Article 83–92: Post-Market Surveillance Requirements Explained https://www.medfortis.org/blog/eu-mdr-article-83-post-market-surveillance https://www.medfortis.org/blog/eu-mdr-article-83-post-market-surveillance Wed, 01 Jul 2026 10:00:00 GMT What Articles 83–92 actually require — the PMS system, PMS plan, PSUR, serious-incident reporting timelines and trend reporting, explained in plain terms.