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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 ISO 13485:2016 Medical Device QMS Transition Training TNF Public On-Site
Medical Device Training Medical Device Single Audit Program (MDSAP) Training SAF 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 Updated!   ISO 14971 Medical Device Risk Management Training RMF Public On-Site
Medical Device Training Updated!   QMS Training for Medical Devices: FDA 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!   Medical Device Vigilance Training: Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management CHF Public On-Site
Medical Device Training 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 DBF Public On-Site
Medical Device Training Medical Device 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 NEW!   SOP Writing and Process Mapping for Medical Device Regulations
(ISO 13485, MDSAP and EU MDR 2017/745)
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!   Medical Device 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 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 ISO 13485:2016 Medical Device QMS Transition Training TNF Public On-Site
ISO 13485 Training & Consulting Understanding an ISO 13485 Quality Management System QSF 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!   QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public On-Site
ISO 13485 Training & Consulting Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
PBF Public On-Site
Transition to ISO 13485:2016 ISO 13485:2016 Medical Device QMS Transition Training TNF Public On-Site
Transition to the MDSAP Medical Device Single Audit Program (MDSAP) Training SAF 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
FDA 510(k) Submissions 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 Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] Training WSF Public On-Site
CAPA Program Support Updated!   Medical Device Vigilance Training: Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management 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
ISO 14971:2012 - Medical Device Risk Management Consultants Updated!   ISO 14971 Medical Device Risk Management 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!   QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 GRF Public On-Site
CE Mark For Medical Devices Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] Training WSF Public On-Site
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