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Oriel STAT A MATRIX provides public training across the United States on 17+ Medical Device RA/QA topics including EU MDRISO 13485 and Risk Management. We also offer online, virtual instructor-led training, and all of our courses can be customized and presented at a location of your choice.  Contact us to learn more.

See our calendar of virtual instructor-led classes.

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Topic Course Name Code Public On-Site
Medical Device RA/QA
Medical Device Training ISO 13485 Lead Auditor Training LAF Public On-Site
Medical Device Training New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public On-Site
Medical Device Training EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
Medical Device Training EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
Medical Device Training New!   ISO 14971:2019 Update Training RUF Public On-Site
Medical Device Training Updated!   ISO 14971 Medical Device Risk Management Training RMF Public On-Site
Medical Device Training QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public On-Site
Medical Device Training New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public
Medical Device Training New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
Medical Device Training ISO 13485 Internal Auditor Training IAF On-Site
Medical Device Training Medical Device Complaint Management and Vigilance Training CHF Public On-Site
Medical Device Training Medical Device Software Development, Verification, and Validation Training SVF Public On-Site
Medical Device Training Medical Device Supplier Quality Management Training SQF Public On-Site
Medical Device Training Design Control Training for Medical Devices: Requirements and Best Practices DBF Public On-Site
Medical Device Training Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program AMF Public On-Site
Medical Device Training Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition SAF On-Site
Medical Device Training Process Validation Training for Medical Devices: Principles and Protocols PVF Public On-Site
Medical Device Training Medical Device CAPA Training: Optimizing Your Programs CAF Public On-Site
Medical Device Training SOP Writing and Process Mapping for Medical Device Regulations
(ISO 13485, MDSAP and EU MDR 2017/745)
DOF On-Site
Medical Device Training Medical Device Root Cause Analysis Training RCF On-Site
Medical Device Training Understanding FDA’s Medical Device Quality System Regulation MGF On-Site
Medical Device Training US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF On-Site
Medical Device Training Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
PBF On-Site
ISO 13485:2016 Implementation ISO 13485 Lead Auditor Training LAF Public On-Site
ISO 13485:2016 Implementation EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
ISO 13485:2016 Implementation QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public On-Site
ISO 13485:2016 Implementation ISO 13485 Internal Auditor Training IAF On-Site
ISO 13485:2016 Implementation Understanding an ISO 13485 Quality Management System QSF On-Site
ISO 13485:2016 Implementation Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
PBF On-Site
MDSAP Auditing Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program AMF Public On-Site
MDSAP Auditing Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition SAF On-Site
EU MDR (2017/745) Consulting New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public On-Site
EU MDR (2017/745) Consulting EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
EU MDR (2017/745) Consulting EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
EU MDR (2017/745) Consulting New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
EU MDR Gap Assessment New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public On-Site
EU MDR Gap Assessment EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
EU MDR Gap Assessment EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
EU MDR Gap Assessment New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
EU IVDR (2017/746) Consulting New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public
EU IVDR (2017/746) Consulting New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
EU Clinical Evaluation Reports (CER) New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public On-Site
EU Clinical Evaluation Reports (CER) EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
EU Clinical Evaluation Reports (CER) EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
US FDA 510(k) Submissions US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF On-Site
CAPA Process Consulting Medical Device Complaint Management and Vigilance Training CHF Public On-Site
CAPA Process Consulting Medical Device CAPA Training: Optimizing Your Programs CAF Public On-Site
CAPA Process Consulting Medical Device Root Cause Analysis Training RCF On-Site
US FDA PMA Preparation US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF On-Site
ISO 14971 & Risk Management New!   ISO 14971:2019 Update Training RUF Public On-Site
ISO 14971 & Risk Management Updated!   ISO 14971 Medical Device Risk Management Training RMF Public On-Site
Medical Device CE Certification EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
Medical Device CE Certification EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
Medical Device CE Certification QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public On-Site
In Vitro Diagnostics (IVD) Compliance Consulting New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746) LIF Public
Medical Device CE Certification New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
Medical Device CE Certification US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF On-Site
ISO 9000 & Related Standards
ISO 9001 ISO 9001 Lead Auditor Training LAI On-Site
ISO 9001 ISO 9001 Internal Auditor Training IAI On-Site
ISO 13485 ISO 13485 Lead Auditor Training LAF Public On-Site
ISO 13485 QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public On-Site
ISO 13485 ISO 13485 Internal Auditor Training IAF On-Site
ISO 13485 Understanding an ISO 13485 Quality Management System QSF On-Site
Performance Excellence
Lean Six Sigma Lean Practitioners Certification LPS On-Site
Lean Six Sigma Lean Six Sigma Black Belt Certification Training BL1 On-Site
Lean Six Sigma Lean Six Sigma Champion Certification CL3 On-Site
Lean Six Sigma Lean Six Sigma Green Belt Certification GL1 On-Site
Lean Six Sigma Lean Six Sigma Master Black Belt Certification MA5 On-Site
Lean Lean Practitioners Certification LPS On-Site
Lean Planning and Leading Lean Kaizen Events VKL On-Site
Lean Targeted Lean Event LTE On-Site
Six Sigma DMAIC Six Sigma DMAIC Black Belt Certification SB1 On-Site
Six Sigma DMAIC Six Sigma DMAIC Green Belt Certification S1S On-Site
Six Sigma DMAIC Six Sigma Green Belt Upgrade to Black Belt Certification GBB On-Site
Design for Six Sigma DMADV Design for Six Sigma D15 On-Site
Teams Optimizing Teams for Success TGS On-Site
Voice of the Customer Listening to the Voice of the Customer VC3 On-Site
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