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Oriel STAT A MATRIX provides public training across the United States on 21+ Medical Device RA/QA topics including EU MDR, ISO 13485 and Risk Management. We also offer online, virtual instructor-led training, and all of our courses can be customized and presented as private trainings for your organization.  Contact us to learn more.
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Topic Course Name Code Public Private
Medical Device RA/QA
Medical Device RA/QA Training ISO 13485 Lead Auditor Training LAF Public Private
Medical Device RA/QA Training EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public Private
Medical Device RA/QA Training Implementing the EU’s New Medical Device Regulation (MDR 2017/745) EMF Public Private
Medical Device RA/QA Training Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program AMF Public Private
Medical Device RA/QA Training QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public Private
Medical Device RA/QA Training New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public Private
Medical Device RA/QA Training ISO 14971 Medical Device Risk Management Training RMF Public Private
Medical Device RA/QA Training New!   ISO 14971:2019 Update Training RUF Public Private
Medical Device RA/QA Training CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
Medical Device RA/QA Training New!   Conducting a Remote Medical Device QMS Audit RAF Public Private
Medical Device RA/QA Training Medical Device Software Development, Verification, and Validation Training SVF Public Private
Medical Device RA/QA Training New!   Medical Device Cybersecurity Risk Management Training CRS Public Private
Medical Device RA/QA Training New!   Medical Device Data Integrity and 21 CFR Part 11 Training DIS Public Private
Medical Device RA/QA Training Medical Device Complaint Handling, Event Reporting, and Recall Management Training CHF Public Private
Medical Device RA/QA Training New!   Medical Device Postmarket Surveillance (PMS) Implementation Training PSF Public Private
Medical Device RA/QA Training Design Control Training for Medical Devices: Requirements and Best Practices DBF Public Private
Medical Device RA/QA Training New!   QMS Software Validation Training for Medical Device Companies QSS Public Private
Medical Device RA/QA Training Implementing the EU's New In Vitro Diagnostic Regulation Training (IVDR 2017/746) EIF Public Private
Medical Device RA/QA Training Process Validation Training for Medical Devices: Principles and Protocols PVF Public Private
Medical Device RA/QA Training Medical Device Supplier Quality Management Training SQF Public Private
Medical Device RA/QA Training Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition SAF Private
Medical Device RA/QA Training Medical Device CAPA Training: Optimizing Your Programs CAF Public Private
Medical Device RA/QA Training Medical Device Root Cause Analysis Training RCF Public Private
Medical Device RA/QA Training US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Private
Medical Device RA/QA Training ISO 13485 Internal Auditor Training IAF Public Private
Medical Device RA/QA Training SOP Writing and Process Mapping for Medical Device Regulations
(ISO 13485, MDSAP and EU MDR 2017/745)
 		DOF Public Private
Medical Device RA/QA Training Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
 		PBF Private
Medical Device RA/QA Training Understanding FDA’s Medical Device Quality System Regulation MGF Private
Medical Device QMS Auditing ISO 13485 Lead Auditor Training LAF Public Private
Medical Device QMS Auditing EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public Private
Medical Device QMS Auditing Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program AMF Public Private
Medical Device QMS Auditing New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public Private
Medical Device QMS Auditing New!   Conducting a Remote Medical Device QMS Audit RAF Public Private
Medical Device QMS Auditing ISO 13485 Internal Auditor Training IAF Public Private
ISO 13485:2016 ISO 13485 Lead Auditor Training LAF Public Private
ISO 13485:2016 QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public Private
ISO 13485:2016 ISO 13485 Internal Auditor Training IAF Public Private
MDSAP Auditing Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program AMF Public Private
MDSAP Auditing Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition SAF Private
ISO 14971 / Risk Management ISO 14971 Medical Device Risk Management Training RMF Public Private
ISO 14971 / Risk Management New!   ISO 14971:2019 Update Training RUF Public Private
CAPA Process Consulting Medical Device Complaint Handling, Event Reporting, and Recall Management Training CHF Public Private
CAPA Process Consulting Medical Device CAPA Training: Optimizing Your Programs CAF Public Private
CAPA Process Consulting Medical Device Root Cause Analysis Training RCF Public Private
EU MDR (2017/745) EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public Private
EU MDR (2017/745) Implementing the EU’s New Medical Device Regulation (MDR 2017/745) EMF Public Private
EU MDR (2017/745) CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
EU Clinical Evaluation Reports (CER) CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
EU IVDR (2017/746) Consulting New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public Private
EU IVDR (2017/746) Consulting Implementing the EU's New In Vitro Diagnostic Regulation Training (IVDR 2017/746) EIF Public Private
US FDA 510(k) Submissions US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Private
ISO 9000 & Related Standards
ISO 13485 ISO 13485 Lead Auditor Training LAF Public Private
ISO 13485 QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public Private
ISO 13485 ISO 13485 Internal Auditor Training IAF Public Private
ISO 9001 ISO 9001 Lead Auditor Training LAI Private
ISO 9001 ISO 9001 Internal Auditor Training IAI Private
ISO 27001 New!   Medical Device Cybersecurity Risk Management Training CRS Public Private
Performance Excellence
Lean Six Sigma Lean Six Sigma Black Belt Certification Training BL1 Private
Lean Six Sigma Lean Six Sigma Champion Certification CL3 Private
Lean Six Sigma Lean Six Sigma Green Belt Certification GL1 Private
Lean Six Sigma Lean Six Sigma Master Black Belt Certification MA5 Private
Design for Six Sigma DMADV Design for Six Sigma D15 Private
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Phone: 1.800.472.6477
Fax: 732.548.4085
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