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Oriel STAT A MATRIX | Medical Device Training, Consulting & Audits My Account | [0] | CONTACT US Medical Device Regulatory / Quality Training & Consulting Need Assistance? 1.800.472.6477 Home About Us Our People Who We Serve Office Locations Our Name Employment how we work Consulting & Auditing Performance Excellence Lean Six Sigma Lean Six Sigma DMAIC Design for Six Sigma DMADV Lean Six Sigma for Healthcare Teams Voice of the Customer Rent a Lean Six Sigma Black Belt ISO 9000 & Related Standards Management System Documentation & Implementation ISO 9001 ISO 13485 Medical Device RA/QA Medical Device Training ISO 13485:2016 Implementation MDSAP Auditing EU MDR (2017/745) Consulting EU MDR Gap Assessment EU IVDR (2017/746) Consulting EU Clinical Evaluation Reports (CER) Medical Device QMS Audits US FDA 510(k) Submissions Device QMS Implementation CAPA Process Consulting US FDA PMA Preparation ISO 14971 & Risk Management US FDA 483 Mitigation Medical Device CE Certification Lean Six Sigma Consulting RA/QA Outsourcing Quality System Audits for ISO 13485, FDA QSR, MDSAP Preassessment & FDA Mock Audits Internal Audits - ISO 13485, FDA QSR, MDSAP Supplier Audits Auditor Training Performance-Based Auditing Remote, Virtual Medical Device Audits Find a Training Course All Courses Medical Device RA/QA Virtual Instructor-Led Classes ISO 9000 & Related Standards Performance Excellence Professional Certification Programs Resources White Papers and Market Updates Case Studies Blog Can't travel? Don't worry. Online, virtual instructor-led training brings our most popular RA/QA classes to the comfort of your home or office. Learn More The EU MDR compliance clock is ticking down Oriel STAT A MATRIX can help with Readiness Audits, CERs, Risk Assessments, Technical Files, and training. Learn More Health and Safety Policy Steps Oriel STAT A MATRIX is taking to ensure we continue to provide a safe environment for customers, staff, consultants, and instructors during the coronavirus outbreak. Learn More Stay ahead of fast-moving medical device regulatory changes. Choose from one of 19 classes – offered in 12 US cities – each taught by experienced instructors in an unmatched hands-on format that’s been fine-tuned over 50 years Learn More New! Transition to the New EU Medical Device Regulation (MDR) The MDR brings major changes to premarket and postmarket requirements for medical devices in the EU. Learn More New! Transition to the New EU In Vitro Diagnostic Regulation (IVDR) Get ready! The IVDR Is far more comprehensive than the IVDD it will replace. Learn More The Oriel STAT A MATRIX View Access timely insights on performance excellence and RA/QA topics from Oriel STAT A MATRIX thought leaders. Learn More Medical Device RA/QA Consulting Quality System Implementation: QSR, MDSAP, ISO 13485 EU MDR Compliance CER Writing EU IVDR Complaince FDA 510(k) Submissions Warning Letters & 483 Assistance All Consulting QMS Auditing Preassessment & FDA Mock Audits Internal Audits - ISO 13485, MDSAP, FDA QSR EU MDR Gap Analysis MDSAP Audits Supplier Audits Auditor Training All Auditing Training Online Virtual Classes ISO 13485 Lead Auditor Training EU MDR Auditor Training NEW! EU IVDR Transition Training Updated: ISO 14971 Risk Management Training NEW! CER Training for EU MDR Compliance All Training Get to know us... Since 1968, Oriel STAT A MATRIX has provided organizations with the business process management tools they need to meet global regulatory requirements, increase quality, efficiency, and profitability . Whether you are beginning a new performance improvement initiative or expanding an existing one, Oriel STAT A MATRIX provides best-in-class performance improvement training and consulting solutions - including FDA-regulated services, implementation of ISO 9000, and continual improvement methods such as Lean Six Sigma - that enhance financial results and customer satisfaction. LEARN MORE How can we help you? For immediate assistance, please call 1.800.472.6477 Contact Us 1095 Morris Avenue Suite 103B Union, NJ 07083 Phone: 1.800.472.6477 Fax: 732.548.4085 International Offices Online DOWNLOAD About Us Contact Us Blog Employment Consulting & Auditing › Medical Device RA/QA › ISO 9000 & Related Standards › Performance Excellence › MDSAP, ISO 13845, QSR, & EU MDR Find a Training Course © Oriel STAT A MATRIX. All Rights Resrved. | Site Map | Privacy and Legal We use cookies to help us offer you the best online experience. By continuing to use our website or closing this window, you’re providing consent regarding cookies. If you want to learn more read our Privacy Policy . OK × Privacy and Legal Updated February 13, 2020 Oriel STAT A MATRIX is committed to protecting the privacy of those using our website and the confidentiality of the personal information that visitors and customers share with us. 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