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Oriel STAT A MATRIX provides public training across the United States on 22+ Medical Device RA/QA topics including EU MDRISO 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

ISO 13485 Lead Auditor Training Course

Topic Medical Device RA/QA Training

Code LAF

Code
LAF
Public
Public
Private
Private

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

Topic Medical Device RA/QA Training

Code LEF

Code
LEF
Public
Public
Private
Private

EU MDR 2017/745 Implementation Training Course

Topic Medical Device RA/QA Training

Code EMF

Code
EMF
Public
Public
Private
Private

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

Topic Medical Device RA/QA Training

Code AMF

Code
AMF
Public
Public
Private
Private

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

Topic Medical Device RA/QA Training

Code GRF

Code
GRF
Public
Public
Private
Private

Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Topic Medical Device RA/QA Training

Code UDF

Code
UDF
Public
Public
Private
Private

EU IVDR Auditor Training

Topic Medical Device RA/QA Training

Code LIF

Code
LIF
Public
Public
Private
Private

New! Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device RA/QA Training

Code IMF

Code
IMF
Public
Private
Private

ISO 14971 Medical Device Risk Management Training

Topic Medical Device RA/QA Training

Code RMF

Code
RMF
Public
Public
Private
Private

ISO 14971:2019 Update Training

Topic Medical Device RA/QA Training

Code RUF

Code
RUF
Public
Private
Private

New! Medical Device Non-Product Software Validation Training

Topic Medical Device RA/QA Training

Code NPS

Code
NPS
Public
Public
Private
Private

CER (Clinical Evaluation Report) Training for EU MDR Compliance

Topic Medical Device RA/QA Training

Code ECF

Code
ECF
Public
Public
Private
Private

New! Conducting Remote Medical Device QMS Audit Training

Topic Medical Device RA/QA Training

Code RAF

Code
RAF
Public
Public
Private
Private

Medical Device Cybersecurity Risk Management Standards & Regulations Training Course

Topic Medical Device RA/QA Training

Code CRS

Code
CRS
Public
Public
Private
Private

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
Public
Private
Private

New! Combination Product Device Supplier Management Training

Topic Medical Device RA/QA Training

Code SQP

Code
SQP
Public
Public
Private
Private

New! Managing Risks in Combination Products and Drug Delivery Systems

Topic Medical Device RA/QA Training

Code RMP

Code
RMP
Public
Public
Private
Private

New! Medical Device Software Regulations and Standards Training

Topic Medical Device RA/QA Training

Code RAS

Code
RAS
Public
Public
Private
Private

Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance Training

Topic Medical Device RA/QA Training

Code DIS

Code
DIS
Public
Public
Private
Private

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

Topic Medical Device RA/QA Training

Code CHF

Code
CHF
Public
Public
Private
Private

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

Topic Medical Device RA/QA Training

Code PSF

Code
PSF
Public
Public
Private
Private

Design Control Training for Medical Devices: Requirements and Best Practices

Topic Medical Device RA/QA Training

Code DBF

Code
DBF
Public
Public
Private
Private

New! CAPA and Root Cause Investigation Training for Medical Devices

Topic Medical Device RA/QA Training

Code CRF

Code
CRF
Public
Public
Private
Private

New! Combination Products: From Regulatory Strategy to Postmarket Surveillance

Topic Medical Device RA/QA Training

Code CPP

Code
CPP
Public
Public
Private
Private

New! Medical Device Software Development Life Cycle Training

Topic Medical Device RA/QA Training

Code SLS

Code
SLS
Public
Public
Private
Private

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
Public
Private
Private

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
Public
Private
Private

Process Validation Training for Medical Devices: Principles and Protocols

Topic Medical Device RA/QA Training

Code PVF

Code
PVF
Public
Public
Private
Private

Medical Device Supplier Quality Management Training

Topic Medical Device RA/QA Training

Code SQF

Code
SQF
Public
Public
Private
Private

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

Topic Medical Device RA/QA Training

Code SAF

Code
SAF
Public
Private
Private

Medical Device CAPA Training: Optimizing Your Programs

Topic Medical Device RA/QA Training

Code CAF

Code
CAF
Public
Private
Private

Medical Device Root Cause Analysis Training Course

Topic Medical Device RA/QA Training

Code RCF

Code
RCF
Public
Private
Private

US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training

Topic Medical Device RA/QA Training

Code WSF

Code
WSF
Public
Public
Private
Private

ISO 13485 Internal Auditor Training

Topic Medical Device RA/QA Training

Code IAF

Code
IAF
Public
Public
Private
Private

SOP Writing and Process Mapping for Medical Device Regulations

Topic Medical Device RA/QA Training

Code DOF

Code
DOF
Public
Public
Private
Private

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
Private
Private

Understanding FDA’s Medical Device Quality System Regulation

Topic Medical Device RA/QA Training

Code MGF

Code
MGF
Public
Private
Private

ISO 13485 Lead Auditor Training Course

Topic Medical Device QMS Auditing

Code LAF

Code
LAF
Public
Public
Private
Private

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

Topic Medical Device QMS Auditing

Code LEF

Code
LEF
Public
Public
Private
Private

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

Topic Medical Device QMS Auditing

Code AMF

Code
AMF
Public
Public
Private
Private

EU IVDR Auditor Training

Topic Medical Device QMS Auditing

Code LIF

Code
LIF
Public
Public
Private
Private

New! Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device QMS Auditing

Code IMF

Code
IMF
Public
Private
Private

New! Conducting Remote Medical Device QMS Audit Training

Topic Medical Device QMS Auditing

Code RAF

Code
RAF
Public
Public
Private
Private

ISO 13485 Internal Auditor Training

Topic Medical Device QMS Auditing

Code IAF

Code
IAF
Public
Public
Private
Private

ISO 13485 Lead Auditor Training Course

Topic ISO 13485:2016

Code LAF

Code
LAF
Public
Public
Private
Private

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

Topic ISO 13485:2016

Code GRF

Code
GRF
Public
Public
Private
Private

ISO 13485 Internal Auditor Training

Topic ISO 13485:2016

Code IAF

Code
IAF
Public
Public
Private
Private

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

Topic MDSAP Auditing

Code AMF

Code
AMF
Public
Public
Private
Private

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

Topic MDSAP Auditing

Code SAF

Code
SAF
Public
Private
Private

ISO 14971 Medical Device Risk Management Training

Topic ISO 14971 / Risk Management

Code RMF

Code
RMF
Public
Public
Private
Private

ISO 14971:2019 Update Training

Topic ISO 14971 / Risk Management

Code RUF

Code
RUF
Public
Private
Private

New! Managing Risks in Combination Products and Drug Delivery Systems

Topic ISO 14971 / Risk Management

Code RMP

Code
RMP
Public
Public
Private
Private

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

Topic CAPA & Root Cause Analysis

Code CHF

Code
CHF
Public
Public
Private
Private

New! CAPA and Root Cause Investigation Training for Medical Devices

Topic CAPA & Root Cause Analysis

Code CRF

Code
CRF
Public
Public
Private
Private

Medical Device CAPA Training: Optimizing Your Programs

Topic CAPA & Root Cause Analysis

Code CAF

Code
CAF
Public
Private
Private

Medical Device Root Cause Analysis Training Course

Topic CAPA & Root Cause Analysis

Code RCF

Code
RCF
Public
Private
Private

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

Topic EU MDR (2017/745)

Code LEF

Code
LEF
Public
Public
Private
Private

EU MDR 2017/745 Implementation Training Course

Topic EU MDR (2017/745)

Code EMF

Code
EMF
Public
Public
Private
Private

Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Topic EU MDR (2017/745)

Code UDF

Code
UDF
Public
Public
Private
Private

CER (Clinical Evaluation Report) Training for EU MDR Compliance

Topic EU MDR (2017/745)

Code ECF

Code
ECF
Public
Public
Private
Private

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

Topic EU MDR (2017/745)

Code PSF

Code
PSF
Public
Public
Private
Private

CER (Clinical Evaluation Report) Training for EU MDR Compliance

Topic EU Clinical Evaluation Reports (CER)

Code ECF

Code
ECF
Public
Public
Private
Private

Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Topic EU IVDR (2017/746)

Code UDF

Code
UDF
Public
Public
Private
Private

EU IVDR Auditor Training

Topic EU IVDR (2017/746)

Code LIF

Code
LIF
Public
Public
Private
Private

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

Topic EU IVDR (2017/746)

Code PSF

Code
PSF
Public
Public
Private
Private

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

Topic EU IVDR (2017/746)

Code EIF

Code
EIF
Public
Public
Private
Private

New! Medical Device Non-Product Software Validation Training

Topic Non-Product Software Validation

Code NPS

Code
NPS
Public
Public
Private
Private

US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training

Topic US FDA 510(k) Submissions

Code WSF

Code
WSF
Public
Public
Private
Private

Pharmaceutical RA/QA

New! Applying Usability Principles to Drug Delivery Systems with IEC 62366-1:2020

Topic Regulatory Compliance for Pharmaceuticals

Code UDP

Code
UDP
Public
Public
Private
Private

New! Combination Product Device Supplier Management Training

Topic Regulatory Compliance for Pharmaceuticals

Code SQP

Code
SQP
Public
Public
Private
Private

New! Managing Risks in Combination Products and Drug Delivery Systems

Topic Regulatory Compliance for Pharmaceuticals

Code RMP

Code
RMP
Public
Public
Private
Private

New! Combination Products: From Regulatory Strategy to Postmarket Surveillance

Topic Regulatory Compliance for Pharmaceuticals

Code CPP

Code
CPP
Public
Public
Private
Private

New! Process Validation in the Pharmaceutical Industry

Topic Regulatory Compliance for Pharmaceuticals

Code PVP

Code
PVP
Public
Public
Private
Private

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
Public
Private
Private

ISO 9000 & Related Standards

ISO 13485 Lead Auditor Training Course

Topic ISO 13485

Code LAF

Code
LAF
Public
Public
Private
Private

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

Topic ISO 13485

Code GRF

Code
GRF
Public
Public
Private
Private

ISO 13485 Internal Auditor Training

Topic ISO 13485

Code IAF

Code
IAF
Public
Public
Private
Private

ISO 9001 Lead Auditor Training

Topic ISO 9001

Code LAI

Code
LAI
Public
Public
Private
Private

ISO 9001:2015 Internal Auditor Training

Topic ISO 9001

Code IAI

Code
IAI
Public
Private
Private

Medical Device Cybersecurity Risk Management Standards & Regulations Training Course

Topic ISO 27001

Code CRS

Code
CRS
Public
Public
Private
Private

Performance Excellence

Lean Six Sigma Black Belt Certification Training

Topic Lean Six Sigma

Code BL1

Code
BL1
Public
Private
Private

Lean Six Sigma Champion Certification

Topic Lean Six Sigma

Code CL3

Code
CL3
Public
Private
Private

Lean Six Sigma Green Belt Certification

Topic Lean Six Sigma

Code GL1

Code
GL1
Public
Private
Private

Lean Six Sigma Master Black Belt Certification

Topic Lean Six Sigma

Code MA5

Code
MA5
Public
Private
Private

Design for Six Sigma

Topic Design for Six Sigma DMADV

Code D15

Code
D15
Public
Private
Private

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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