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. 

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Medical Device RA/QA

New! Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device QMS Auditing

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New! QMS Training for Medical Devices: ISO 13485:2016 and FDA QMSR

Topic Medical Device RA/QA Training

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ISO 13485 Lead Auditor Training Course

Topic Medical Device RA/QA Training

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New! Transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) - DaySmart Series

Topic Medical Device RA/QA Training

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ISO 14971 Medical Device Risk Management and Analysis Training

Topic Medical Device RA/QA Training

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Medical Device QMS Overview Training

Topic Medical Device RA/QA Training

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Medical Device CAPA and Root Cause Investigation Training

Topic Medical Device RA/QA Training

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Medical Device Design Control Training

Topic Medical Device RA/QA Training

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EU MDR Auditor Training Course for Europe’s Medical Device Regulation (2017/745)

Topic Medical Device RA/QA Training

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EU MDR Training for the European Medical Device Regulation (2017/745)

Topic Medical Device RA/QA Training

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ISO 13485 Internal Auditor Training Class

Topic Medical Device RA/QA Training

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Medical Device Single Audit Program (MDSAP) Internal Auditor Training

Topic Medical Device RA/QA Training

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Medical Device Complaint Handling, Event Reporting, and Recall Management Training

Topic Medical Device RA/QA Training

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EU MDR CER (Clinical Evaluation Report) Training for Medical Devices

Topic Medical Device RA/QA Training

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Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training

Topic Medical Device RA/QA Training

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Medical Device Supplier and Subcontractor Quality Management Training

Topic Medical Device RA/QA Training

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Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Topic Medical Device RA/QA Training

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Understanding FDA’s Medical Device Quality System Regulation

Topic Medical Device RA/QA Training

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New! Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device RA/QA Training

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Medical Device Process Validation Training Course: FDA and ISO 13485 Requirements

Topic Medical Device RA/QA Training

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Medical Device Production and QMS Software Validation Training

Topic Medical Device RA/QA Training

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ISO 13485 Overview Training for Medical Device and IVD Manufacturers

Topic Medical Device RA/QA Training

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ISO 9001 Internal Auditor Training

Topic Medical Device RA/QA Training

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Combination Device Supplier Management Training

Topic Medical Device RA/QA Training

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EU IVDR Auditor Training Class (2017/746)

Topic Medical Device RA/QA Training

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Medical Device Cybersecurity Risk Management, Regulations and Standards Training

Topic Medical Device RA/QA Training

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EU In Vitro Diagnostic Regulation Overview Training (IVDR 2017/746)

Topic Medical Device RA/QA Training

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Medical Device Postmarket Surveillance (PMS) Training

Topic Medical Device RA/QA Training

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FDA and EU Medical Device Software Regulations and Standards Training

Topic Medical Device RA/QA Training

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FDA and EU Medical Device Labeling Requirements Training

Topic Medical Device RA/QA Training

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Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device RA/QA Training

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Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device RA/QA Training

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FDA and EU Medical Device Classification and Regulatory Pathway Training

Topic Medical Device RA/QA Training

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ISO 14971 and Risk Management Training for Combination Drug-Device-Biologic Products

Topic Medical Device RA/QA Training

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Medical Device Single Audit Program (MDSAP) Training

Topic Medical Device RA/QA Training

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FDA 21 CFR Part 11 Training: Pharmaceutical Data Integrity, ALCOA+, and Electronic Records

Topic Medical Device RA/QA Training

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FDA Part 11 Compliance and Medical Device Data Integrity Training

Topic Medical Device RA/QA Training

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ISO 9001:2015 Lead Auditor Training Course

Topic Medical Device RA/QA Training

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Lean Six Sigma Champion Training Course

Topic Medical Device RA/QA Training

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Lean Six Sigma Champion Training Course

Topic Medical Device RA/QA Training

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US FDA and EU Regulatory Requirements Training for Combination Products

Topic Medical Device RA/QA Training

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Design Control Training for Drug-Device and Other Combination Products

Topic Medical Device RA/QA Training

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Medical Device SOP Writing and Process Mapping Training

Topic Medical Device RA/QA Training

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FDA GMP Inspection and For Cause Audit Training for Combination Products

Topic Medical Device RA/QA Training

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Lean Six Sigma Black Belt Certification Training

Topic Medical Device RA/QA Training

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Lean Six Sigma Black Belt Certification Training

Topic Medical Device RA/QA Training

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Lean Six Sigma Master Black Belt Certification Training Course

Topic Medical Device RA/QA Training

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Lean Six Sigma Master Black Belt Certification Training Course

Topic Medical Device RA/QA Training

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Training on How to Conduct a Remote Medical Device QMS Audit

Topic Medical Device RA/QA Training

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Root Cause Analysis for Combination Products and Drug Delivery Systems

Topic Medical Device RA/QA Training

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Root Cause Analysis for Combination Products and Drug Delivery Systems

Topic Medical Device RA/QA Training

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Medical Device Human Factors Usability and IEC 62366 Training

Topic Medical Device RA/QA Training

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Drug Delivery System Human Factors and Usability Requirements Training

Topic Medical Device RA/QA Training

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