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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 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 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 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
Transition to ISO 13485:2016 ISO 13485:2016 Medical Device QMS Transition Training TNF Public On-Site
FDA and Canada MDSAP Audit Certification Consulting Medical Device Single Audit Program (MDSAP) Training:
Preparing for a Successful Transition
SAF Public On-Site
EU MDR (2017/745) Medical Device Compliance Consulting New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
FDA and Canada MDSAP Audit Certification Consulting New!   Internal Auditing to MDSAP:
Concepts and Practices in Aligning the Internal Audit Program
AMF Public On-Site
Medical Device 510(k) Submission Consulting for FDA Clearance US FDA 510(k) and EU CE Marking Medical Device Registration Strategy 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 US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public On-Site
Medical Device CAPA (Corrective and Preventive Action) Process Consultants Updated!   Medical Device Vigilance Training:
Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management
CHF Public On-Site
Medical Device CAPA (Corrective and Preventive Action) Process Consultants Optimizing CAPA Programs for the Medical Device Industry Training CAF Public On-Site
Medical Device CAPA (Corrective and Preventive Action) Process Consultants 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
Medical Device CE Marking Certification Consulting for Europe New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
Medical Device CE Marking Certification Consulting for Europe QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
GRF Public On-Site
Medical Device CE Marking Certification Consulting for Europe US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF Public On-Site
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