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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 Six Sigma DMAIC Teams Voice of the Customer Lean Design for Six Sigma DMADV Lean Six Sigma for Healthcare Rent a Lean Six Sigma Black Belt ISO 9000 & Related Standards Management System Documentation & Implementation ISO 13485 ISO 9001 ISO 27001 Medical Device RA/QA Medical Device RA/QA Training EU MDR (2017/745) Emergency Use Authorizations (EUA) ISO 13485:2016 ISO 14971 / Risk Management EU MDR Gap Assessment MDSAP Auditing EU Clinical Evaluation Reports (CER) EU IVDR (2017/746) US FDA 510(k) Submissions Medical Device QMS Auditing QMS Implementation CAPA Process Consulting US FDA PMA Preparation 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 Auditor Training Supplier Audits Performance-Based Auditing Remote Medical Device Audits Connected Medical Devices, SaMD & IoMT ISO 27001 ISMS & Cybersecurity Software Validation and Verification Find a Training Course All Courses Medical Device RA/QA Virtual Instructor-Led Classes ISO 9000 & Related Standards Performance Excellence Private Team Training Resources White Papers and Market Updates Case Studies Blog The EU MDR has been postponed. Keep calm and carry on. Oriel STAT A MATRIX can help with Remote Audits, CERs, Risk Assessments, Technical Files, and virtual training. Learn More Can't travel? Don't worry. Virtual instructor-led training. Our most popular RA/QA classes are available in an online instructor-led format. Expect the same engaging instruction as you get in our in-person workshops. Learn More US FDA EUA in Response to COVID-19 Is this fast-track clearance pathway a viable option for your medical device or IVD? 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 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 Emergency Use Authorization (EUA) Quality System Implementation: QSR, MDSAP, ISO 13485 EU MDR Compliance CER / MEDDEV 2.7/1 Rev. 4 FDA 510(k) Submissions Warning Letters & 483 Assistance All Consulting QMS Auditing Remote Audits - ISO, FDA, MDSAP, EU MDR Preassessment & FDA Mock Audits Internal Audits - ISO 13485, MDSAP, FDA QSR EU MDR Gap Analysis 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 › Connected Medical Technology › 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. 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