# Ran Chen Author Profile Ran Chen is a machine learning leader with over a decade of experience driving AI innovation across media, real estate, and legal tech. Chief Technology OfficerUnited States / Americas26 articles ## About Ran Chen With deep technical expertise in personalization, computer vision, and natural language processing, Chen has built and scaled end-to-end machine learning systems that power user experiences, optimize engagement, and accelerate business growth. Chen has a proven track record of managing distributed teams, fostering a culture of experimentation, and delivering scalable, data-driven solutions from scratch. Prior to joining Pure Global, he served as the founding machine learning engineer and later Director of Engineering at Tubi TV, where he led the development of core recommendation engines, experimentation platforms, and international personalization strategies for a platform serving over 100 million users. He holds a Master of Computational Data Science from Carnegie Mellon University and a Bachelor of Software Engineering from Tsinghua University in Beijing. Published by Ran Chen ## Latest Articles [ View all resources ](https://www.pureglobal.com/resources/blog) [ November 16, 2026 Launching a Medical Device in the U.S. in 2026 Work through FDA pathway selection, registration, U.S. Agent and importer roles, QMSR readiness, and customs entry with two worked examples. ](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026)[ November 9, 2026 Device Classification and Clinical Evidence Across Four Markets in 2026 Assess device classification and clinical-data pathways across Japan, Vietnam, the US and EU, with dated registration and cost evidence. ](https://www.pureglobal.com/blog-posts/apac-eu-us-device-classification-clinical-pathway-divergence-japan-vietnam-mdr-2026)[ November 2, 2026 Device Change Control: A Five-Market Release Plan for 2026 Classify device changes in five markets, identify local release conditions, and separate annual representation fees from government charges. ](https://www.pureglobal.com/blog-posts/apac-latam-post-approval-device-change-control-singapore-malaysia-hongkong-mexico-2026)[ October 26, 2026 FDA 510(k) Pathway Selection: Evidence, Review Clocks and Costs in 2026 A data-backed guide to Traditional, Special, Abbreviated and third-party 510(k) decisions, with clear limits on what historical clearance times can predict. ](https://www.pureglobal.com/blog-posts/us-fda-510k-pathway-selection-3p510k-estar-review-clocks-2026)[ October 19, 2026 Team-NB MDR Documentation: Submission Completeness Checks (2026) Interpret Team-NB’s notified-body completeness survey correctly and turn MDR technical-documentation guidance into a scoped evidence and submission check. ](https://www.pureglobal.com/blog-posts/team-nb-mdr-technical-documentation-completeness-2026)[ October 14, 2026 21 CFR Part 820 to ISO 13485: The QMSR Crosswalk QMSR cut 21 CFR Part 820 from 31 sections to six and made ISO 13485:2016 the rule. This crosswalk maps every old section to its ISO 13485 clause, marks which mappings FDA stated, lists the FDA-only requirements and shows where a decade of 483 citations now lands. ](https://www.pureglobal.com/blog-posts/fda-21-cfr-part-820-to-iso-13485-qmsr-crosswalk-guide)[ October 14, 2026 FDA Cleared vs Approved vs Granted: 510(k), PMA and De Novo In 2025 FDA cleared 3,198 devices through 510(k), granted 27 De Novo requests and approved 38 original PMAs. This guide explains what each word means legally, how long each route takes, what it costs in FY2027 and how to describe your device's status without misbranding it. ](https://www.pureglobal.com/blog-posts/fda-cleared-vs-approved-vs-granted-510k-pma-de-novo)[ October 14, 2026 FDA Inspection Readiness Checklist (QMSR) FDA now inspects device makers under the QMSR and Compliance Program 7382.850. Our analysis of ten years of FDA Form 483 data shows where investigators find problems, and the 12-point checklist turns those findings into records to prepare before the investigator arrives. ](https://www.pureglobal.com/blog-posts/fda-inspection-readiness-checklist-for-medical-device-manufacturers)[ October 14, 2026 FDA Medical Device Classification: Class I, II and III Explained FDA's October 2026 product code file puts 36.5% of classified codes in Class I, 55.4% in Class II and 8.0% in Class III. This guide explains what each class requires, why class alone does not decide the pathway, and how to confirm your device's class in six steps. ](https://www.pureglobal.com/blog-posts/fda-medical-device-classification-class-i-ii-iii-guide)[ October 14, 2026 SaMD vs SiMD: Software as a Medical Device under FDA and EU MDR Software as a Medical Device performs a medical purpose on its own; software in a medical device drives hardware. This guide explains how the difference changes classification under FDA and EU MDR Rule 11, what a submission needs in 2026 and what FDA's list of 1,614 AI-enabled devices shows. ](https://www.pureglobal.com/blog-posts/samd-software-as-a-medical-device-fda-eu-mdr-guide)[ October 12, 2026 EUDAMED Registration Deadlines for Devices and Certificates in 2026 Separate mandatory use, device-registration backlog and certificate deadlines before judging an EUDAMED record or planning the next submission. ](https://www.pureglobal.com/blog-posts/eudamed-registration-clocks-2026)[ October 5, 2026 China GMP inspections: outsourcing registrants from November 2026 Prepare for 1 November 2026 with a verified comparison of the registrant’s and manufacturer’s minimum inspection chapters, graded requirements and release responsibilities. ](https://www.pureglobal.com/blog-posts/china-gmp-outsourcing-inspection-checklist-november-2026)[ September 28, 2026 QMSR Warning Letters 2026: The ISO 13485 Records FDA Named Four posted FDA warning letters cite ISO 13485:2016 Clause 7.1 and name the missing records. Pull those first, then management-review and audit reports. ](https://www.pureglobal.com/blog-posts/qmsr-warning-letters-iso-13485-records-2026)[ September 21, 2026 ISO 14971 Risk Files: Evidence and Review Use recall data, regulatory sources and worked examples to review risk controls and the evidence supporting release. ](https://www.pureglobal.com/blog-posts/iso-14971-risk-management-file-2026)[ September 14, 2026 In-Country Representatives and Registration Holders: 2026 Guide Who holds the file matters when a distributor changes. Compare local roles, handover documents, transfer conditions and the full annual cost before appointing a partner. ](https://www.pureglobal.com/blog-posts/in-country-representative-registration-holder-decision-2026)[ September 6, 2026 One Device, Three UDI Databases (2026): Build the US, EU and China Work Order Shared identifiers need separate regulatory mappings. Use corrected database evidence, product-specific calendars and a scoped cost breakdown to plan the work. ](https://www.pureglobal.com/blog-posts/udi-us-eu-china-compliance-workorder-2026)[ August 31, 2026 Medical Device Technical File Compilation Cost (2026): Build, Buy, or Hybrid? Technical-file quotes are incomparable until scope, writing, gap closure, reviewer responses, lifecycle maintenance, and authority fees are separated. This report combines public price lines, FDA workload data, EU survey evidence, and a break-even model to show when to build internally, buy a project, or use a hybrid team. ](https://www.pureglobal.com/blog-posts/medical-device-technical-file-compilation-cost-2026)[ August 24, 2026 Medical Device Registration Verification 2026: What 15 National Public Data Files Actually Contain A public register is not a market map. This workpaper names what one row means, which identity fields are filled, and where verification still needs in-country evidence. ](https://www.pureglobal.com/blog-posts/medical-device-registration-verification-2026) [Canonical page](https://www.pureglobal.com/authors/ran-chen)