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Oriel STAT A MATRIX provides public training across the United States on 22+ 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 Course LAF Public Private
Medical Device RA/QA Training EU MDR Auditor Training Course (Europe’s Medical Device Regulation 2017/745) LEF Public Private
Medical Device RA/QA Training EU MDR 2017/745 Implementation Training Course 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 Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366 UDF Public Private
Medical Device RA/QA Training EU IVDR Auditor Training LIF Public Private
Medical Device RA/QA Training New!   Inspection and Audit Readiness Training for Medical Device Manufacturers IMF Private
Medical Device RA/QA Training ISO 14971 Medical Device Risk Management Training RMF Public Private
Medical Device RA/QA Training ISO 14971:2019 Update Training RUF Private
Medical Device RA/QA Training New!   Medical Device Non-Product Software Validation Training NPS 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 Remote Medical Device QMS Audit Training RAF Public Private
Medical Device RA/QA Training Medical Device Cybersecurity Risk Management Standards & Regulations Training Course CRS Public Private
Medical Device RA/QA Training Medical Device Software Development, Verification, and Validation Training (IEC 62304 and ISO 13485:2016) SVF Public Private
Medical Device RA/QA Training New!   Applying Usability Principles to Drug Delivery Systems with IEC 62366-1:2020 UDP Public Private
Medical Device RA/QA Training New!   Medical Device Software Regulations and Standards Training RAS Public Private
Medical Device RA/QA Training Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance 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) Program 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!   CAPA and Root Cause Investigation Training for Medical Devices CRF Public Private
Medical Device RA/QA Training New!   Combination Products: From Regulatory Strategy to Postmarket Surveillance CPP Public Private
Medical Device RA/QA Training New!   Managing Risks in Combination Products and Drug Delivery Systems RMP Public Private
Medical Device RA/QA Training New!   Medical Device Software Development Life Cycle Training SLS Public Private
Medical Device RA/QA Training New!   Process Validation in the Pharmaceutical Industry PVP Public Private
Medical Device RA/QA Training New!   QMS Software Validation Training for Medical Device Companies Meeting FDA and ISO 13485 Requirements QSS Public Private
Medical Device RA/QA Training Data Integrity and Electronic Records Training for Pharmaceutical Companies (ALCOA+ and FDA 21 CFR Part 11) DIP Public Private
Medical Device RA/QA Training Implementing the EU's New In Vitro Diagnostic Regulation Training Course (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 Implementation SAF Private
Medical Device RA/QA Training Medical Device CAPA Training Course: Optimizing Your Programs CAF Private
Medical Device RA/QA Training Medical Device Root Cause Analysis Training Course RCF Private
Medical Device RA/QA Training US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public 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 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 Course LAF Public Private
Medical Device QMS Auditing EU MDR Auditor Training Course (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 EU IVDR Auditor Training LIF Public Private
Medical Device QMS Auditing New!   Inspection and Audit Readiness Training for Medical Device Manufacturers IMF Private
Medical Device QMS Auditing New!   Conducting Remote Medical Device QMS Audit Training RAF Public Private
Medical Device QMS Auditing ISO 13485 Internal Auditor Training IAF Public Private
ISO 13485:2016 ISO 13485 Lead Auditor Training Course 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 Implementation SAF Private
ISO 14971 / Risk Management ISO 14971 Medical Device Risk Management Training RMF Public Private
ISO 14971 / Risk Management ISO 14971:2019 Update Training RUF Private
CAPA & Root Cause Analysis Medical Device Complaint Handling, Event Reporting, and Recall Management Training CHF Public Private
CAPA & Root Cause Analysis New!   CAPA and Root Cause Investigation Training for Medical Devices CRF Public Private
CAPA & Root Cause Analysis Medical Device CAPA Training Course: Optimizing Your Programs CAF Private
CAPA & Root Cause Analysis Medical Device Root Cause Analysis Training Course RCF Private
EU MDR (2017/745) EU MDR Auditor Training Course (Europe’s Medical Device Regulation 2017/745) LEF Public Private
EU MDR (2017/745) EU MDR 2017/745 Implementation Training Course EMF Public Private
EU MDR (2017/745) Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366 UDF Public Private
EU MDR (2017/745) CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
EU MDR (2017/745) New!   Medical Device Postmarket Surveillance (PMS) Program Implementation Training PSF Public Private
EU Clinical Evaluation Reports (CER) CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public Private
EU IVDR (2017/746) Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366 UDF Public Private
EU IVDR (2017/746) EU IVDR Auditor Training LIF Public Private
EU IVDR (2017/746) New!   Medical Device Postmarket Surveillance (PMS) Program Implementation Training PSF Public Private
EU IVDR (2017/746) Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746) EIF Public Private
Non-Product Software Validation New!   Medical Device Non-Product Software Validation Training NPS Public Private
US FDA 510(k) Submissions US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public Private
ISO 9000 & Related Standards
ISO 13485 ISO 13485 Lead Auditor Training Course 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 Public Private
ISO 9001 ISO 9001:2015 Internal Auditor Training IAI Private
ISO 27001 Medical Device Cybersecurity Risk Management Standards & Regulations Training Course 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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