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Oriel STAT A MATRIX provides public training across the United States on 17+ 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.

See our calendar of virtual instructor-led classes.
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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 EU MDR Transition Training (Europe’s Medical Device Regulation 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 Updated!   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 New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF 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!   Conducting a Remote Medical Device QMS Audit RAF Public Private
Medical Device RA/QA Training Medical Device Complaint Management and Vigilance Training CHF 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!   EU IVDD to IVDR Transition Training (EU 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 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
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 13485:2016 Implementation ISO 13485 Lead Auditor Training LAF Public Private
EU MDR (2017/745) EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public Private
EU MDR (2017/745) EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public Private
ISO 13485:2016 Implementation QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public Private
EU MDR (2017/745) New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
ISO 13485:2016 Implementation Understanding an ISO 13485 Quality Management System QSF Private
ISO 13485:2016 Implementation ISO 13485 Internal Auditor Training IAF Public Private
ISO 13485:2016 Implementation Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
 		PBF Private
EU MDR Gap Assessment EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public Private
EU MDR Gap Assessment EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public Private
EU MDR Gap Assessment New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
EU IVDR (2017/746) New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public Private
EU IVDR (2017/746) New!   EU IVDD to IVDR Transition Training (EU IVDR (2017/746)) EIF Public Private
EU Clinical Evaluation Reports (CER) EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public Private
EU Clinical Evaluation Reports (CER) EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public Private
EU Clinical Evaluation Reports (CER) New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
US FDA 510(k) Submissions US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Private
CAPA Process Consulting Medical Device Complaint Management and Vigilance 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
US FDA PMA Preparation US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Private
ISO 14971 / Risk Management Updated!   ISO 14971 Medical Device Risk Management Training RMF Public Private
ISO 14971 / Risk Management New!   ISO 14971:2019 Update Training RUF Public Private
Medical Device CE Certification EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public Private
Medical Device CE Certification EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public Private
Medical Device CE Certification QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public Private
In Vitro Diagnostics (IVD) Compliance Consulting New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public Private
Medical Device CE Certification New!   EU IVDD to IVDR Transition Training (EU IVDR (2017/746)) EIF Public Private
Medical Device CE Certification US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Private
ISO 9000 & Related Standards
ISO 9001 ISO 9001 Lead Auditor Training LAI Private
ISO 9001 ISO 9001 Internal Auditor Training IAI Private
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 27001 New!   Medical Device Cybersecurity Risk Management Training CRS Public Private
ISO 13485 Understanding an ISO 13485 Quality Management System QSF Private
ISO 13485 ISO 13485 Internal Auditor Training IAF Public Private
Performance Excellence
Lean Six Sigma Lean Practitioners Certification LPS Private
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
Lean Lean Practitioners Certification LPS Private
Lean Planning and Leading Lean Kaizen Events VKL Private
Lean Targeted Lean Event LTE Private
Six Sigma DMAIC Six Sigma DMAIC Black Belt Certification SB1 Private
Six Sigma DMAIC Six Sigma DMAIC Green Belt Certification S1S Private
Six Sigma DMAIC Six Sigma Green Belt Upgrade to Black Belt Certification GBB Private
Design for Six Sigma DMADV Design for Six Sigma D15 Private
Teams Optimizing Teams for Success TGS Private
Voice of the Customer Listening to the Voice of the Customer VC3 Private
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Oriel Stat

1095 Morris Avenue
Suite 103B
Union, NJ 07083

Phone: 1.800.472.6477
Fax: 732.548.4085
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