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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:
Preparing for a Successful Transition
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 New!   Internal Auditing to MDSAP:
Concepts and Practices in Aligning the Internal Audit Program
AMF Public On-Site
Medical Device Training QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
GRF Public On-Site
Medical Device Training Updated!   ISO 14971 Medical Device Risk Management Training RMF Public On-Site
Medical Device Training Updated!   Medical Device Supplier Quality Management Training 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 US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public On-Site
Medical Device Training Design Control Training for Medical Devices:
Requirements and Best Practices
DBF Public On-Site
Medical Device Training Process Validation Training for Medical Devices:
Principles and Protocols
PVF Public On-Site
Medical Device Training Optimizing CAPA Programs for the Medical Device Industry Training CAF Public On-Site
Medical Device Training Updated!   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 Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
PBF 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 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 On-Site
ISO 13485:2016 Transition ISO 13485:2016 Medical Device QMS Transition Training TNF Public On-Site
MDSAP Auditing Medical Device Single Audit Program (MDSAP) Training:
Preparing for a Successful Transition
SAF Public On-Site
EU MDR (2017/745) Transition New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
MDSAP Auditing New!   Internal Auditing to MDSAP:
Concepts and Practices in Aligning the Internal Audit Program
AMF Public On-Site
US FDA 510(k) US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public On-Site
EU CER & MEDDEV 2.7/1 New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
US FDA PMA Submission US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public On-Site
CAPA Process Consulting Updated!   Medical Device Vigilance Training:
Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management
CHF Public On-Site
CAPA Process Consulting Optimizing CAPA Programs for the Medical Device Industry Training CAF Public On-Site
CAPA Process Consulting Root Cause Analysis for Life Science Investigations Training RCF Public On-Site
ISO 14971 & Risk Management Updated!   ISO 14971 Medical Device Risk Management Training RMF Public On-Site
EU CE Marking Certification New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
EU CE Marking Certification QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
GRF Public On-Site
EU CE Marking Certification US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public On-Site
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