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US: 1.800.472.6477 | EU: +353 21 212 8530 0 Contact us [0] | Let’s get started Contact us QA/RA Consulting, Auditing & Training HomeOur People Who We Serve Partners Employment Consulting & Auditing Medical Device RA/QA EU MDR (2017/745) Compliance ISO 27001 ISMS & Cybersecurity Software Validation and Verification ISO 14971 Risk Management EU CE Mark Certification FDA Software Classification Lean Six Sigma EU MDR Gap Analysis EU MDR Clinical Evaluation Reports PMS Process Evaluation PMS Program Outsourcing EU IVDR Consulting Non-Product Software Validation FDA Premarket Approval FDA 510(k) Submissions FDA Q-Submission GDocP Documentation Support FDA IDE Submissions Emergency Use Authorizations (EUA) FDA 483 Mitigation RA/QA Staff Augmentation Medical Device RA/QA Training EU IVDR Gap Analysis Biological Evaluation Reports EU IVDR Performance Evaluation QMS Compliance ISO 13485 Certification Consulting FDA 21 CFR 820 Implementation QMS Compliance for Software MDSAP Internal Audits Medical Device QMS Auditing FDA QSIT Mock Audits CAPA & Root Cause Analysis Critical Supplier Audits FDA 21 CFR Part 11 Compliance ISO 27001 Compliance ISO 9001 Compliance ISO 13485 Management System Documentation Auditor Training QMS Implementation Internal QMS Audits Performance-Based Auditing Remote Medical Device Audits FIND A TRAINING COURSE All Courses Upcoming courses in next 90 days Medical Device RA/QA Virtual Instructor-Led Classes Pharmaceutical RA/QA RAC Certification Private Team Training eLearning - Medical Device RA/QA Certificación Costa Rica Resources Blog Consulting & Auditing QMS Compliance ISO 13485 Certification Consulting FDA 21 CFR 820 Implementation QMS Compliance for Software MDSAP Internal Audits Medical Device QMS Auditing FDA QSIT Mock Audits CAPA & Root Cause Analysis Critical Supplier Audits FDA 21 CFR Part 11 Compliance ISO 27001 Compliance ISO 9001 Compliance ISO 13485 Management System Documentation Auditor Training QMS Implementation Internal QMS Audits Performance-Based Auditing Remote Medical Device Audits Medical Device RA/QA EU MDR (2017/745) Compliance ISO 27001 ISMS & Cybersecurity Software Validation and Verification ISO 14971 Risk Management EU CE Mark Certification FDA Software Classification Lean Six Sigma EU MDR Gap Analysis EU MDR Clinical Evaluation Reports PMS Process Evaluation PMS Program Outsourcing EU IVDR Consulting Non-Product Software Validation FDA Premarket Approval FDA 510(k) Submissions FDA Q-Submission GDocP Documentation Support FDA IDE Submissions Emergency Use Authorizations (EUA) FDA 483 Mitigation RA/QA Staff Augmentation Medical Device RA/QA Training EU IVDR Gap Analysis Biological Evaluation Reports EU IVDR Performance Evaluation Pharmaceutical RA/QA how we work Consulting Services Staff Augmentation Find a Training Course All Courses Resources White Papers and Market Updates Case Studies Blog 25 EU MDR Requirements That Apply to Legacy MDD Devices Right NOW Think you have years to comply with the EU MDR? Think again. Your Notified Body expects you to be fully compliant with these MDR requirements NOW. Are You Prepared For Your Next FDA Inspection or Notified Body Audit? Eliminate surprises. Let our team of specialist medical device QMS auditors determine whether you meet the requirements of 21 CFR Part 820, ISO 13485 and/or MDSAP. Medical Device Clinical Evaluation Reports Giving You Heartburn? Notified Bodies expect to see robust clinical data in accordance with MEDDEV 2.7/1 Rev 4 but many companies struggle to meet strict CER requirements. We can help. NEW! DaySmart Training Classes. One Day and Done — Only $995! Need to get up-to-speed quickly but don’t have the time, need, or budget for an intensive multiday class? DaySmart classes are for you. EU Medical Device Regulation Compliance Making Your Head Spin? You’re not alone: the MDR is way more complex than the MDD it replaces. Find out where you stand in terms of MDR compliance with an EU MDD to MDR gap analysis. Learn how. Short Staffed? Experiencing Project Overload? Whether you’re a start-up that needs short-term RA/QA expertise, or an established company with more projects than staff to handle them, we can help. Learn how. Implementing the New EU In Vitro Diagnostic Regulation (IVDR) The IVDR is far more comprehensive than the IVDD it replaced. Let us help you follow the new requirements. 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Since 1968, Oriel STAT A MATRIX has helped medical device and diagnostic manufacturers improve performance, achieve regulatory compliance, and secure sustainable success. Life sciences companies rely on our subject matter expertise, experience supporting industry leaders, and ability to deliver results that matter. Oriel STAT A MATRIX’s Goal Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes HOW CAN WE HELP YOU? 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Site Map Privacy and Legal Call Search Cart 0 My Account Menu HomeOverview Our People Who We Serve Partners Employment CONSULTING & AUDITING Overview Medical Device RA/QA EU MDR (2017/745) Compliance ISO 27001 ISMS & Cybersecurity Software Validation and Verification ISO 14971 Risk Management EU CE Mark Certification FDA Software Classification Lean Six Sigma EU MDR Gap Analysis EU MDR Clinical Evaluation Reports PMS Process Evaluation PMS Program Outsourcing EU IVDR Consulting Non-Product Software Validation FDA Premarket Approval FDA 510(k) Submissions FDA Q-Submission GDocP Documentation Support FDA IDE Submissions Emergency Use Authorizations (EUA) FDA 483 Mitigation RA/QA Staff Augmentation Medical Device RA/QA Training EU IVDR Gap Analysis Biological Evaluation Reports EU IVDR Performance Evaluation QMS Compliance ISO 13485 Certification Consulting FDA 21 CFR 820 Implementation QMS Compliance for Software MDSAP Internal Audits Medical Device QMS Auditing FDA QSIT Mock Audits CAPA & Root Cause Analysis Critical Supplier Audits FDA 21 CFR Part 11 Compliance ISO 27001 Compliance ISO 9001 Compliance ISO 13485 Management System Documentation Auditor Training QMS Implementation Internal QMS Audits Performance-Based Auditing Remote Medical Device Audits Pharmaceutical RA/QA FIND A TRAINING COURSE All Courses Upcoming courses in next 90 days Medical Device RA/QA Virtual Instructor-Led Classes Pharmaceutical RA/QA RAC Certification Private...