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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 New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public On-Site
Medical Device Training EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
Medical Device Training Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program AMF Public On-Site
Medical Device Training New!   EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
Medical Device Training ISO 14971 Medical Device Risk Management Training RMF Public On-Site
Medical Device Training QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
GRF Public On-Site
Medical Device Training New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF 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 Complaint Management and Vigilance Training CHF 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 Medical Device Supplier Quality Management Training SQF Public On-Site
Medical Device Training US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF 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 Medical Device CAPA Training: Optimizing Your Programs CAF Public On-Site
Medical Device Training SOP Writing and Process Mapping for Medical Device Regulations
(ISO 13485, MDSAP and EU MDR 2017/745)
DOF On-Site
Medical Device Training Medical Device Root Cause Analysis Training RCF 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 Medical Device Software Development, Verification, and Validation 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 13485:2016 Implementation ISO 13485 Lead Auditor Training LAF Public On-Site
ISO 13485:2016 Implementation Understanding an ISO 13485 Quality Management System QSF On-Site
ISO 13485:2016 Implementation EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
ISO 13485:2016 Implementation QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
GRF Public On-Site
ISO 13485:2016 Implementation ISO 13485 Internal Auditor Training IAF Public On-Site
ISO 13485:2016 Implementation ISO 13485:2016 Medical Device QMS Transition Training TNF Public On-Site
ISO 13485:2016 Implementation 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
EU MDR (2017/745) Consulting New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public On-Site
EU MDR (2017/745) Consulting EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
MDSAP Auditing Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program AMF Public On-Site
EU MDR (2017/745) Consulting New!   EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
EU MDR (2017/745) Consulting New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
MDSAP Auditing Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition SAF Public On-Site
EU IVDR (2017/746) Consulting New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
US FDA 510(k) Submissions US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF On-Site
EU Clinical Evaluation Reports (CER) New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance ECF Public On-Site
EU Clinical Evaluation Reports (CER) EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
EU Clinical Evaluation Reports (CER) New!   EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
US FDA PMA Preparation US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF On-Site
CAPA Process Consulting Medical Device Complaint Management and Vigilance Training CHF Public On-Site
CAPA Process Consulting Medical Device CAPA Training: Optimizing Your Programs CAF Public On-Site
CAPA Process Consulting Medical Device Root Cause Analysis Training RCF On-Site
ISO 14971 & Risk Management ISO 14971 Medical Device Risk Management Training RMF Public On-Site
Medical Device CE Certification EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) EMF Public On-Site
Medical Device CE Certification New!   EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745) LEF Public On-Site
Medical Device CE Certification QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
GRF Public On-Site
Medical Device CE Certification New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746) EIF Public On-Site
Medical Device CE Certification US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training WSF On-Site
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