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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 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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Medical Device RA/QA

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

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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LAF
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EU MDR 2017/745 Implementation Training Course

Topic Medical Device RA/QA Training

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EMF
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Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Topic Medical Device RA/QA Training

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QMS Training for Medical Devices: FDA QSR and ISO 13485:2016

Topic Medical Device RA/QA Training

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Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Topic Medical Device RA/QA Training

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New! Design Control for Combination Products

Topic Medical Device RA/QA Training

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EU IVDR Training for Auditors

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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ISO 14971 Medical Device Risk Management Training

Topic Medical Device RA/QA Training

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ISO 14971:2019 Update Training

Topic Medical Device RA/QA Training

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New! Medical Device Non-Product Software Validation Training

Topic Medical Device RA/QA Training

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CER (Clinical Evaluation Report) Training for EU MDR Compliance

Topic Medical Device RA/QA Training

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New! Conducting Remote Medical Device QMS Audit Training

Topic Medical Device RA/QA Training

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Medical Device Cybersecurity Risk Management Standards & Regulations Training Course

Topic Medical Device RA/QA Training

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Medical Device Software Development, Verification, and Validation Training (IEC 62304 and ISO 13485:2016)

Topic Medical Device RA/QA Training

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New! Combination Product Device Supplier Management Training

Topic Medical Device RA/QA Training

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New! Managing Risks in Combination Products and Drug Delivery Systems

Topic Medical Device RA/QA Training

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New! Medical Device Software Regulations and Standards Training

Topic Medical Device RA/QA Training

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

Topic Medical Device RA/QA Training

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Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance 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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New! Medical Device Postmarket Surveillance (PMS) Program Implementation Training

Topic Medical Device RA/QA Training

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Design Control Training for Medical Devices: Requirements and Best Practices

Topic Medical Device RA/QA Training

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New! CAPA and Root Cause Investigation Training for Medical Devices

Topic Medical Device RA/QA Training

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New! Combination Products: From Regulatory Strategy to Postmarket Surveillance

Topic Medical Device RA/QA Training

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New! Medical Device Software Development Life Cycle Training

Topic Medical Device RA/QA Training

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New! QMS Software Validation Training for Medical Device Companies Meeting FDA and ISO 13485 Requirements

Topic Medical Device RA/QA Training

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Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746)

Topic Medical Device RA/QA Training

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Process Validation Training for Medical Devices: Principles and Protocols

Topic Medical Device RA/QA Training

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Medical Device Supplier Quality Management Training

Topic Medical Device RA/QA Training

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Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Implementation

Topic Medical Device RA/QA Training

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Medical Device CAPA Training: Optimizing Your Programs

Topic Medical Device RA/QA Training

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Medical Device Root Cause Analysis Training Course

Topic Medical Device RA/QA Training

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Understanding Medical Device Classification and Regulatory Pathways

Topic Medical Device RA/QA Training

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ISO 13485 Internal Auditor Training

Topic Medical Device RA/QA Training

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SOP Writing and Process Mapping for Medical Device Regulations

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

Topic Medical Device QMS Auditing

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LEF
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ISO 13485 Lead Auditor Training Course

Topic Medical Device QMS Auditing

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Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Topic Medical Device QMS Auditing

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EU IVDR Training for Auditors

Topic Medical Device QMS Auditing

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New! Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device QMS Auditing

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IMF
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New! Conducting Remote Medical Device QMS Audit Training

Topic Medical Device QMS Auditing

Code RAF

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RAF
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ISO 13485 Internal Auditor Training

Topic Medical Device QMS Auditing

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ISO 13485 Lead Auditor Training Course

Topic ISO 13485:2016

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LAF
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QMS Training for Medical Devices: FDA QSR and ISO 13485:2016

Topic ISO 13485:2016

Code GRF

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GRF
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ISO 13485 Internal Auditor Training

Topic ISO 13485:2016

Code IAF

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IAF
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Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Topic MDSAP Auditing

Code AMF

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AMF
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Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Implementation

Topic MDSAP Auditing

Code SAF

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SAF
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ISO 14971 Medical Device Risk Management Training

Topic ISO 14971 / Risk Management

Code RMF

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RMF
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ISO 14971:2019 Update Training

Topic ISO 14971 / Risk Management

Code RUF

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RUF
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New! Managing Risks in Combination Products and Drug Delivery Systems

Topic ISO 14971 / Risk Management

Code RMP

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

Topic CAPA & Root Cause Analysis

Code CHF

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CHF
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New! CAPA and Root Cause Investigation Training for Medical Devices

Topic CAPA & Root Cause Analysis

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CRF
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Medical Device CAPA Training: Optimizing Your Programs

Topic CAPA & Root Cause Analysis

Code CAF

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CAF
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Medical Device Root Cause Analysis Training Course

Topic CAPA & Root Cause Analysis

Code RCF

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

Topic EU MDR (2017/745)

Code LEF

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LEF
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EU MDR 2017/745 Implementation Training Course

Topic EU MDR (2017/745)

Code EMF

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EMF
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Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Topic EU MDR (2017/745)

Code UDF

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UDF
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CER (Clinical Evaluation Report) Training for EU MDR Compliance

Topic EU MDR (2017/745)

Code ECF

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

Topic EU MDR (2017/745)

Code PSF

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PSF
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CER (Clinical Evaluation Report) Training for EU MDR Compliance

Topic EU Clinical Evaluation Reports (CER)

Code ECF

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ECF
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Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Topic EU IVDR (2017/746)

Code UDF

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UDF
Public
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EU IVDR Training for Auditors

Topic EU IVDR (2017/746)

Code LIF

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

Topic EU IVDR (2017/746)

Code EPF

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

Topic EU IVDR (2017/746)

Code PSF

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PSF
Public
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Private
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Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746)

Topic EU IVDR (2017/746)

Code EIF

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EIF
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New! Medical Device Non-Product Software Validation Training

Topic Non-Product Software Validation

Code NPS

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Understanding Medical Device Classification and Regulatory Pathways

Topic US FDA 510(k) Submissions

Code WSF

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WSF
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