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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. Conveniently offered in 12 cities across the US, Ireland, Costa Rica, and Germany.

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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 Training TNF Public On-Site
Medical Device Training New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
Medical Device Training New!   Transition to the Medical Device Single Audit Program (MDSAP) Training SAF Public On-Site
Medical Device Training Risk Management for Medical Devices: ISO 14971 Training RMF Public On-Site
Medical Device Training Updated!   Quality Systems for Medical Devices Training: FDA’s QSR and ISO 13485:2016 GRF Public On-Site
Medical Device Training Supplier Quality Management Training: Designing a Successful Program SQF Public On-Site
Medical Device Training Updated!   Complaint Handling, Vigilance Reporting, and Recall Management: From Compliance to Best Practices Training CHF Public On-Site
Medical Device Training Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] Training WSF Public On-Site
Medical Device Training Implementing Design Control Requirements and Best Practices Training DBF Public On-Site
Medical Device Training Process Validation Principles and Protocols Training PVF Public On-Site
Medical Device Training Optimizing CAPA Programs for the Medical Device Industry Training CAF Public On-Site
Medical Device Training Updated!   Medical Device Document Management: Developing and Maintaining a Compliant System DOF Public On-Site
Medical Device Training Root Cause Analysis for Life Science Investigations Training 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 Updated!   Software Verification and Validation Requirements Training 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 Training TNF Public On-Site
ISO 13485 Training & Consulting New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
ISO 13485 Training & Consulting Updated!   Quality Systems for Medical Devices Training: 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 Training TNF Public On-Site
Transition to the new EU Medical Device Regulation (MDR) New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
Transition to the MDSAP New!   Transition to the Medical Device Single Audit Program (MDSAP) Training SAF Public On-Site
FDA 510(k) Submissions Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] Training WSF Public On-Site
Clinical Evaluation Report (CER) Development & Transition Support New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF 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] Training WSF Public On-Site
CAPA Program Support Updated!   Complaint Handling, Vigilance Reporting, and Recall Management: From Compliance to Best Practices Training CHF Public On-Site
CAPA Program Support Optimizing CAPA Programs for the Medical Device Industry Training CAF Public On-Site
CAPA Program Support Root Cause Analysis for Life Science Investigations Training RCF Public On-Site
Medical Device Risk Management and Assurance –
ISO 14971
Risk Management for Medical Devices: ISO 14971 Training RMF Public On-Site
CE Mark For Medical Devices New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
CE Mark For Medical Devices Updated!   Quality Systems for Medical Devices Training: 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] Training WSF Public On-Site
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