Medical Device Regulatory Affairs - RA/QA Training Courses

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 as open enrollement classes in 12 US cities and Costa Rica; and as online, virtual training or as private team trainings.

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Filtered by: Medical Device RA/QA

Medical Device RA/QA

EU MDR Training Course for Auditors (Europe’s Medical Device Regulation 2017/745) Topic Medical Device RA/QA Training Code LEF	Code LEF Public View Dates Private Contact Us
ISO 13485 Lead Auditor Training Course Topic Medical Device RA/QA Training Code LAF	Code LAF Public View Dates Private Contact Us
EU MDR 2017/745 Implementation Training Course Topic Medical Device RA/QA Training Code EMF	Code EMF Public View Dates Private Contact Us
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program Topic Medical Device RA/QA Training Code AMF	Code AMF Public View Dates Private Contact Us
QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 Topic Medical Device RA/QA Training Code GRF	Code GRF Public View Dates Private Contact Us
Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366 Topic Medical Device RA/QA Training Code UDF	Code UDF Public View Dates Private Contact Us
New! Design Control for Combination Products Topic Medical Device RA/QA Training Code DCP	Code DCP Public View Dates Private Contact Us
EU IVDR Training for Auditors Topic Medical Device RA/QA Training Code LIF	Code LIF Public View Dates Private Contact Us
New! Inspection and Audit Readiness Training for Medical Device Manufacturers Topic Medical Device RA/QA Training Code IMF	Code IMF Public View Dates Private Contact Us
ISO 14971 Medical Device Risk Management Training Topic Medical Device RA/QA Training Code RMF	Code RMF Public View Dates Private Contact Us
ISO 14971:2019 Update Training Topic Medical Device RA/QA Training Code RUF	Code RUF Public View Dates Private Contact Us
New! Medical Device Non-Product Software Validation Training Topic Medical Device RA/QA Training Code NPS	Code NPS Public View Dates Private Contact Us
CER (Clinical Evaluation Report) Training for EU MDR Compliance Topic Medical Device RA/QA Training Code ECF	Code ECF Public View Dates Private Contact Us
New! Conducting Remote Medical Device QMS Audit Training Topic Medical Device RA/QA Training Code RAF	Code RAF Public View Dates Private Contact Us
Medical Device Cybersecurity Risk Management Standards & Regulations Training Course Topic Medical Device RA/QA Training Code CRS	Code CRS Public View Dates Private Contact Us
Medical Device Software Development, Verification, and Validation Training (IEC 62304 and ISO 13485:2016) Topic Medical Device RA/QA Training Code SVF	Code SVF Public View Dates Private Contact Us
New! Combination Product Device Supplier Management Training Topic Medical Device RA/QA Training Code SQP	Code SQP Public View Dates Private Contact Us
New! Managing Risks in Combination Products and Drug Delivery Systems Topic Medical Device RA/QA Training Code RMP	Code RMP Public View Dates Private Contact Us
New! Medical Device Software Regulations and Standards Training Topic Medical Device RA/QA Training Code RAS	Code RAS Public View Dates Private Contact Us
New! Performance Evaluation Report (PER) Training for EU IVDR Compliance Topic Medical Device RA/QA Training Code EPF	Code EPF Public View Dates Private Contact Us
Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance Training Topic Medical Device RA/QA Training Code DIS	Code DIS Public View Dates Private Contact Us
Medical Device Complaint Handling, Event Reporting, and Recall Management Training Topic Medical Device RA/QA Training Code CHF	Code CHF Public View Dates Private Contact Us
New! Medical Device Postmarket Surveillance (PMS) Program Implementation Training Topic Medical Device RA/QA Training Code PSF	Code PSF Public View Dates Private Contact Us
Design Control Training for Medical Devices: Requirements and Best Practices Topic Medical Device RA/QA Training Code DBF	Code DBF Public View Dates Private Contact Us
New! CAPA and Root Cause Investigation Training for Medical Devices Topic Medical Device RA/QA Training Code CRF	Code CRF Public View Dates Private Contact Us
New! Combination Products: From Regulatory Strategy to Postmarket Surveillance Topic Medical Device RA/QA Training Code CPP	Code CPP Public View Dates Private Contact Us
New! Medical Device Software Development Life Cycle Training Topic Medical Device RA/QA Training Code SLS	Code SLS Public View Dates Private Contact Us
New! QMS Software Validation Training for Medical Device Companies Meeting FDA and ISO 13485 Requirements Topic Medical Device RA/QA Training Code QSS	Code QSS Public View Dates Private Contact Us
Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746) Topic Medical Device RA/QA Training Code EIF	Code EIF Public View Dates Private Contact Us
Process Validation Training for Medical Devices: Principles and Protocols Topic Medical Device RA/QA Training Code PVF	Code PVF Public View Dates Private Contact Us
Medical Device Supplier Quality Management Training Topic Medical Device RA/QA Training Code SQF	Code SQF Public View Dates Private Contact Us
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Implementation Topic Medical Device RA/QA Training Code SAF	Code SAF Public View Dates Private Contact Us
Medical Device CAPA Training: Optimizing Your Programs Topic Medical Device RA/QA Training Code CAF	Code CAF Public View Dates Private Contact Us
Medical Device Root Cause Analysis Training Course Topic Medical Device RA/QA Training Code RCF	Code RCF Public View Dates Private Contact Us
US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training Topic Medical Device RA/QA Training Code WSF	Code WSF Public View Dates Private Contact Us
ISO 13485 Internal Auditor Training Topic Medical Device RA/QA Training Code IAF	Code IAF Public View Dates Private Contact Us
SOP Writing and Process Mapping for Medical Device Regulations Topic Medical Device RA/QA Training Code DOF	Code DOF Public View Dates Private Contact Us
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality Topic Medical Device RA/QA Training Code PBF	Code PBF Public View Dates Private Contact Us
Understanding FDA’s Medical Device Quality System Regulation Topic Medical Device RA/QA Training Code MGF	Code MGF Public View Dates Private Contact Us
EU MDR Training Course for Auditors (Europe’s Medical Device Regulation 2017/745) Topic Medical Device QMS Auditing Code LEF	Code LEF Public View Dates Private Contact Us
ISO 13485 Lead Auditor Training Course Topic Medical Device QMS Auditing Code LAF	Code LAF Public View Dates Private Contact Us
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program Topic Medical Device QMS Auditing Code AMF	Code AMF Public View Dates Private Contact Us
EU IVDR Training for Auditors Topic Medical Device QMS Auditing Code LIF	Code LIF Public View Dates Private Contact Us
New! Inspection and Audit Readiness Training for Medical Device Manufacturers Topic Medical Device QMS Auditing Code IMF	Code IMF Public View Dates Private Contact Us
New! Conducting Remote Medical Device QMS Audit Training Topic Medical Device QMS Auditing Code RAF	Code RAF Public View Dates Private Contact Us
ISO 13485 Internal Auditor Training Topic Medical Device QMS Auditing Code IAF	Code IAF Public View Dates Private Contact Us
ISO 13485 Lead Auditor Training Course Topic ISO 13485:2016 Code LAF	Code LAF Public View Dates Private Contact Us
QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 Topic ISO 13485:2016 Code GRF	Code GRF Public View Dates Private Contact Us
ISO 13485 Internal Auditor Training Topic ISO 13485:2016 Code IAF	Code IAF Public View Dates Private Contact Us
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program Topic MDSAP Auditing Code AMF	Code AMF Public View Dates Private Contact Us
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Implementation Topic MDSAP Auditing Code SAF	Code SAF Public View Dates Private Contact Us
ISO 14971 Medical Device Risk Management Training Topic ISO 14971 / Risk Management Code RMF	Code RMF Public View Dates Private Contact Us
ISO 14971:2019 Update Training Topic ISO 14971 / Risk Management Code RUF	Code RUF Public View Dates Private Contact Us
New! Managing Risks in Combination Products and Drug Delivery Systems Topic ISO 14971 / Risk Management Code RMP	Code RMP Public View Dates Private Contact Us
Medical Device Complaint Handling, Event Reporting, and Recall Management Training Topic CAPA & Root Cause Analysis Code CHF	Code CHF Public View Dates Private Contact Us
New! CAPA and Root Cause Investigation Training for Medical Devices Topic CAPA & Root Cause Analysis Code CRF	Code CRF Public View Dates Private Contact Us
Medical Device CAPA Training: Optimizing Your Programs Topic CAPA & Root Cause Analysis Code CAF	Code CAF Public View Dates Private Contact Us
Medical Device Root Cause Analysis Training Course Topic CAPA & Root Cause Analysis Code RCF	Code RCF Public View Dates Private Contact Us
EU MDR Training Course for Auditors (Europe’s Medical Device Regulation 2017/745) Topic EU MDR (2017/745) Code LEF	Code LEF Public View Dates Private Contact Us
EU MDR 2017/745 Implementation Training Course Topic EU MDR (2017/745) Code EMF	Code EMF Public View Dates Private Contact Us
Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366 Topic EU MDR (2017/745) Code UDF	Code UDF Public View Dates Private Contact Us
CER (Clinical Evaluation Report) Training for EU MDR Compliance Topic EU MDR (2017/745) Code ECF	Code ECF Public View Dates Private Contact Us
New! Medical Device Postmarket Surveillance (PMS) Program Implementation Training Topic EU MDR (2017/745) Code PSF	Code PSF Public View Dates Private Contact Us
CER (Clinical Evaluation Report) Training for EU MDR Compliance Topic EU Clinical Evaluation Reports (CER) Code ECF	Code ECF Public View Dates Private Contact Us
Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366 Topic EU IVDR (2017/746) Code UDF	Code UDF Public View Dates Private Contact Us
EU IVDR Training for Auditors Topic EU IVDR (2017/746) Code LIF	Code LIF Public View Dates Private Contact Us
New! Performance Evaluation Report (PER) Training for EU IVDR Compliance Topic EU IVDR (2017/746) Code EPF	Code EPF Public View Dates Private Contact Us
New! Medical Device Postmarket Surveillance (PMS) Program Implementation Training Topic EU IVDR (2017/746) Code PSF	Code PSF Public View Dates Private Contact Us
Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746) Topic EU IVDR (2017/746) Code EIF	Code EIF Public View Dates Private Contact Us
New! Medical Device Non-Product Software Validation Training Topic Non-Product Software Validation Code NPS	Code NPS Public View Dates Private Contact Us
US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training Topic US FDA 510(k) Submissions Code WSF	Code WSF Public View Dates Private Contact Us

Medical Device RA/QA Training

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New! Design Control for Combination Products

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New! Inspection and Audit Readiness Training for Medical Device Manufacturers

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New! Medical Device Non-Product Software Validation Training

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New! Conducting Remote Medical Device QMS Audit Training

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New! Combination Product Device Supplier Management Training

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New! Managing Risks in Combination Products and Drug Delivery Systems

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New! Medical Device Software Regulations and Standards Training

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New! Performance Evaluation Report (PER) Training for EU IVDR Compliance

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New! Medical Device Postmarket Surveillance (PMS) Program Implementation Training