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You may unsubscribe from these communications at anytime. Please review our privacy policy here. A SPECIAL GLIMPSE INTO MEDTRONIC'S RECENT DEVELOPMENTS IN SPINE & BIOLOGICS TECHNOLOGY By Nick Tippmann on November 17, 2021 Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transfo... GREENLIGHT GURU LAUNCHES GURU ASSIST, ON-DEMAND LIFELINE TO MEDICAL DEVICE EXPERTS By Nick Tippmann on November 17, 2021 New on-demand assistance functionality offers a flexible way to leverage expert medical device suppo... ISO 11135: AN OVERVIEW OF MEDICAL DEVICE STERILIZATION USING ETHYLENE OXIDE By Laura Court on November 16, 2021 Once a medical device has been designed, developed, and manufactured to specifications, it may feel ... HOW TO APPROACH CORRECTIVE ACTION REQUESTS WITH MEDICAL DEVICE SUPPLIERS By Taylor Brown on November 14, 2021 For medical device manufacturers, finding success means setting ourselves up for success with repeat... 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Are they one and the same or different in the medical device indus... * See All Posts * * 1 * 2 * 3 * 4 * 5 * THE GREENLIGHT GURU MEDICAL DEVICE BLOG Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development. OUR MOST POPULAR POSTS * Medical Device Companies - Top 100 in 2020 (Free Chart) * The Ultimate Guide To Design Controls For Medical Device Companies * ISO 14971 Risk Management for Medical Devices: The Definitive Guide * Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? * The Beginner's Guide to Design Verification and Design Validation for Medical Devices * Top 30+ Medical Device Conferences To Attend in 2021 (Virtual + In Person) * Understanding ISO 14971 Medical Device Risk Management * Medical Device Classification Guide - How To Determine Your Device Class * Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices * FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours TOPICS * Medical Device Industry (245) * Global Medical Device Podcast (236) * FDA Regulations (193) * Regulatory Affairs (185) * Quality Management System (QMS) (173) * Regulatory Compliance (144) * Product Development (135) * Medical Device Product (128) * Risk Management (97) * Design Controls (96) * QMS Software (96) * Mike Drues (90) * Process / Planning (80) * True Quality (80) * MedTech Business (75) * ISO 13485 (70) * Medical Device Success Platform (MDSP) (67) * Quality Assurance (46) * Document Management (43) * 510(k) Process (42) * FDA 21 CFR Part 820 (41) * Corrective Action Preventive Action (CAPA) (37) * Electronic Quality Management System (eQMS) (37) * EU MDR (36) * Manufacturing (34) * Press Release (30) * Software as a Medical Device (SaMD) (27) * FDA Inspection (26) * Human Factors (25) * ISO 14971 (25) * Audit Management (24) * Testing (24) * ISO Audit (22) * Traceability (22) * Case Study (21) * ISO Standards (21) * True Quality Stories (21) * Change Management (20) * Complaint Management (20) * EU IVDR (19) * Medical Device Events (19) * User Needs (19) * Postmarket Surveillance (PMS) (18) * Root Cause Analysis (16) * Verification & Validation (16) * Classification (15) * Design History File (DHF) (15) * 483 Observations / Warning Letters (14) * Labeling (13) * Nonconformance Management (13) * Premarket Approval (PMA) (13) * Quality Management (13) * Supplier Management (13) * CE Marking (12) * Funding (12) * Clinical Evaluation (11) * De Novo (11) * Design Reviews (11) * Artificial Intelligence (AI) (10) * Project Management (10) * Medical Device Single Audit Program (MDSAP) (8) * Software Validation (8) * 21 CFR Part 11 (7) * Notified Body (7) * YouTube Video (7) * Computer System Validation (6) * IEC 60601 (6) * Technical File (6) * Training Management (6) * Quality Event (5) * 3D Printing (4) * IEC 62304 (4) * Management Reviews (4) * In Vitro Diagnostic (IVD) Device (3) * QSIT (3) * Investigational Device Exemption (IDE) (2) * Packaging (2) * 21 CFR 812 (1) * ISO 27001 (1) See More Topics... * Solutions * QMS Software Overview * Intelligent Document Management * Greenlight Guru Visualize * Guru Services * For Product Teams * For Quality Teams * For Executives * Software * Design Control * Document Management * Risk Management * Audit Management * Complaint Management * CAPA Management * Nonconformance Mgmt. * Change Management * Training Management * Resources * Greenlight Guru Academy * Free Resources * Blog * Podcasts * In-Person Events * Glossary * Free Webinars * Join Newsletter * Industry Job Board * Become a Partner * Why Switch * Why Greenlight Guru * Company * About us * Customers * Case Studies * Careers * Press * Support * Contact Us * 317-960-4220 * Schedule a Demo * Request Pricing * FAQ * Site Map * Top Downloads * Risk Management Plan Template * FDA QSR/ISO 13485 Internal Audit Checklist * EU MDR Gap Analysis Tool * 15 Steps to Creating a Risk-based CAPA Process * 3 Quality Event Templates © 2021 Greenlight Guru Third party trademarks, logos and trade names appearing on the site are the property of their respective owners. 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