Medical Device Compliance - QA Training Courses

Oriel STAT A MATRIX provides public training across the United States on 22+ Medical Device RA/QA topics including EU MDR, ISO 13485 and Risk Management. We also offer online, virtual instructor-led training, and all of our courses can be customized and presented as private trainings for your organization. Contact us to learn more.

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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 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

Pharmaceutical RA/QA

New! Design Control for Combination Products Topic Regulatory Compliance for Pharmaceuticals Code DCP	Code DCP Public View Dates Private Contact Us
New! Applying Usability Principles to Drug Delivery Systems with IEC 62366-1:2020 Topic Regulatory Compliance for Pharmaceuticals Code UDP	Code UDP Public View Dates Private Contact Us
New! Combination Product Device Supplier Management Training Topic Regulatory Compliance for Pharmaceuticals Code SQP	Code SQP Public View Dates Private Contact Us
New! Managing Risks in Combination Products and Drug Delivery Systems Topic Regulatory Compliance for Pharmaceuticals Code RMP	Code RMP Public View Dates Private Contact Us
New! Combination Products: From Regulatory Strategy to Postmarket Surveillance Topic Regulatory Compliance for Pharmaceuticals Code CPP	Code CPP Public View Dates Private Contact Us
New! Inspection and Audit Readiness Training for Pharmaceutical Manufacturers Topic Regulatory Compliance for Pharmaceuticals Code IRP	Code IRP Public View Dates Private Contact Us
New! Process Validation in the Pharmaceutical Industry Topic Regulatory Compliance for Pharmaceuticals Code PVP	Code PVP Public View Dates Private Contact Us
New! Root Cause Analysis for Combination Products and Drug Delivery Systems Topic Regulatory Compliance for Pharmaceuticals Code RCP	Code RCP Public View Dates Private Contact Us
New! Data Integrity and Electronic Records Training for Pharmaceutical Companies (ALCOA+ and FDA 21 CFR Part 11) Topic Regulatory Compliance for Pharmaceuticals Code DIP	Code DIP Public View Dates Private Contact Us

ISO 9000 & Related Standards

ISO 13485 Lead Auditor Training Course Topic ISO 13485 Code LAF	Code LAF Public View Dates Private Contact Us
QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 Topic ISO 13485 Code GRF	Code GRF Public View Dates Private Contact Us
ISO 13485 Internal Auditor Training Topic ISO 13485 Code IAF	Code IAF Public View Dates Private Contact Us
ISO 9001 Lead Auditor Training Topic ISO 9001 Code LAI	Code LAI Public View Dates Private Contact Us
ISO 9001:2015 Internal Auditor Training Topic ISO 9001 Code IAI	Code IAI Public View Dates Private Contact Us
Medical Device Cybersecurity Risk Management Standards & Regulations Training Course Topic ISO 27001 Code CRS	Code CRS Public View Dates Private Contact Us

Performance Excellence

Lean Six Sigma Black Belt Certification Training Topic Lean Six Sigma Code BL1	Code BL1 Public View Dates Private Contact Us
Lean Six Sigma Champion Certification Topic Lean Six Sigma Code CL3	Code CL3 Public View Dates Private Contact Us
Lean Six Sigma Green Belt Certification Topic Lean Six Sigma Code GL1	Code GL1 Public View Dates Private Contact Us
Lean Six Sigma Master Black Belt Certification Topic Lean Six Sigma Code MA5	Code MA5 Public View Dates Private Contact Us
Design for Six Sigma Topic Design for Six Sigma DMADV Code D15	Code D15 Public View Dates Private Contact Us

RA/QA Training for the Life Sciences Industry

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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