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Medical Device RA/QA Training

We offer basic through advanced courses in quality assurance, regulatory compliance, and accredited training for auditor development. Our course library is monitored constantly to ensure that offerings stay up to date with evolving and changing requirements. Our newest class topics include MDSAP, the new EU MDR, and Transition to ISO 13485:2016 . Contact us to learn more.

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