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Oriel STAT A MATRIX provides public training across the United States on conformance and improvement methodologies such as Lean Six Sigma, Medical Device RA/QA, ISO 9001, and ISO 13485. We also offer Professional Certificate Programs. All of our courses can be customized and presented at a location of your choice.  Contact us to learn more.

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Filtered by: Medical Device RA/QA  (Remove Filter)
Topic Course Name Code Public On-Site
Medical Device RA/QA
Medical Device RA/QA Training ISO 13485 Lead Auditor Training LAF Public On-Site
Medical Device RA/QA Training ISO 13485 Internal Auditor Training IAF Public On-Site
Medical Device RA/QA Training Transition to ISO 13485:2016 TNF Public On-Site
Medical Device RA/QA Training New!   Transition to the Medical Device Single Audit Program (MDSAP) SAF Public On-Site
Medical Device RA/QA Training NEW!   Transition to the New EU Medical Device Regulation (MDR) EMF Public On-Site
Medical Device RA/QA Training Quality Systems for Medical Devices:
FDA’s QSR and ISO 13485:2016
GRF Public On-Site
Medical Device RA/QA Training Risk Management for Medical Devices: ISO 14971 RMF Public On-Site
Medical Device RA/QA Training Complaint Handling, Vigilance Reporting, and Recall Management: From Compliance to Best Practices CHF Public On-Site
Medical Device RA/QA Training Supplier Quality Management: Designing a Successful Program SQF Public On-Site
Medical Device RA/QA Training Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] WSF Public On-Site
Medical Device RA/QA Training Implementing Design Control Requirements and Best Practices DBF Public On-Site
Medical Device RA/QA Training Process Validation Principles and Protocols PVF Public On-Site
Medical Device RA/QA Training Optimizing CAPA Programs for the Medical Device Industry CAF Public On-Site
Medical Device RA/QA Training Developing and Maintaining a Compliant Document Management System DOF Public On-Site
Medical Device RA/QA Training Root Cause Analysis for Life Science Investigations RCF Public On-Site
Medical Device RA/QA Training Understanding FDA’s Medical Device Quality System Regulation MGF On-Site
Medical Device RA/QA Training Calibration Requirements and Equipment Controls for
Medical Devices
CBF Public On-Site
Medical Device RA/QA Training Software Verification and Validation Requirements SVF Public On-Site
Medical Device RA/QA Training Applied Statistics for the Workplace - Advanced DLS On-Site
Medical Device RA/QA Training Applied Statistics for the Workplace – Intermediate ILS On-Site
Medical Device RA/QA Training Applied Statistics for the Workplace – Level 1 BLS On-Site
Medical Device RA/QA Training New!   Performance-Based Auditing for Medical Devices
A Tool for FDA’s Case for Quality
PBF Public On-Site
ISO 13485 Training & Consulting ISO 13485 Lead Auditor Training LAF Public On-Site
ISO 13485 Training & Consulting ISO 13485 Internal Auditor Training IAF Public On-Site
ISO 13485 Training & Consulting Transition to ISO 13485:2016 TNF Public On-Site
ISO 13485 Training & Consulting Understanding an ISO 13485 Quality Management System QSF On-Site
ISO 13485 Training & Consulting NEW!   Transition to the New EU Medical Device Regulation (MDR) EMF Public On-Site
ISO 13485 Training & Consulting Quality Systems for Medical Devices:
FDA’s QSR and ISO 13485:2016
GRF Public On-Site
ISO 13485 Training & Consulting New!   Performance-Based Auditing for Medical Devices
A Tool for FDA’s Case for Quality
PBF Public On-Site
Transition to ISO 13485:2016 Transition to ISO 13485:2016 TNF Public On-Site
Transition to the MDSAP New!   Transition to the Medical Device Single Audit Program (MDSAP) SAF Public On-Site
Transition to the new EU Medical Device Regulation (MDR) and IVD Regulation (IVDR) NEW!   Transition to the New EU Medical Device Regulation (MDR) EMF Public On-Site
FDA 510(k) Submissions Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] WSF Public On-Site
FDA Premarket Approval (PMA) Application Medical Devices Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] WSF Public On-Site
CAPA Program Support Complaint Handling, Vigilance Reporting, and Recall Management: From Compliance to Best Practices CHF Public On-Site
CAPA Program Support Optimizing CAPA Programs for the Medical Device Industry CAF Public On-Site
CAPA Program Support Root Cause Analysis for Life Science Investigations RCF Public On-Site
Medical Device Risk Management and Assurance –
ISO 14971
Risk Management for Medical Devices: ISO 14971 RMF Public On-Site
CE Mark For Medical Devices NEW!   Transition to the New EU Medical Device Regulation (MDR) EMF Public On-Site
CE Mark For Medical Devices Quality Systems for Medical Devices:
FDA’s QSR and ISO 13485:2016
GRF Public On-Site
CE Mark For Medical Devices Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] WSF Public On-Site
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