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Oriel STAT A MATRIX provides public training across the United States on conformance and improvement methodologies such as Lean Six Sigma, Medical Device RA/QA, ISO 9001, and ISO 13485. We also offer Professional Certificate Programs. All of our courses can be customized and presented at a location of your choice. Contact us to learn more.

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Topic	Course Name	Code
Performance Excellence
Lean Six Sigma	Lean Practitioners Certification	LPS
Lean Six Sigma	Lean Six Sigma Black Belt Certification Training	BL1
Lean Six Sigma	Lean Six Sigma Champion Certification	CL3
Lean Six Sigma	Lean Six Sigma Green Belt Certification	GL1
Lean Six Sigma	Lean Six Sigma Master Black Belt Certification	MA5
Lean	Lean Practitioners Certification	LPS
Lean	Planning and Leading Lean Kaizen Events	VKL
Lean	Targeted Lean Event	LTE
Lean	Understanding Lean Enterprise Tools	LNE
Six Sigma DMAIC	Six Sigma DMAIC Black Belt Certification	SB1
Six Sigma DMAIC	Six Sigma DMAIC Green Belt Certification	S1S
Six Sigma DMAIC	Six Sigma Green Belt Upgrade to Black Belt Certification	GBB
Design for Six Sigma DMADV	Design for Six Sigma	D15
Teams	Optimizing Teams for Success	TGS
Applied Statistics for the Workplace	Applied Statistics for the Workplace - Advanced	DLS
Applied Statistics for the Workplace	Applied Statistics for the Workplace – Intermediate	ILS
Applied Statistics for the Workplace	Applied Statistics for the Workplace – Level 1	BLS
Applied Statistics for the Workplace	Understanding and Performing Hypothesis Testing	HYP
Applied Statistics for the Workplace	Conducting Regression Analysis	RGR
Applied Statistics for the Workplace	Applying Design of Experiments (DOE)	DEX
Voice of the Customer	Listening to the Voice of the Customer	VC3
ISO 9000 & Related Standards
ISO 9001	ISO 9001 Lead Auditor Training	LAI
ISO 9001	ISO 9001 Internal Auditor Training	IAI
ISO 9001	Transition to ISO 9001:2015	TRI
ISO 9001	Risk Management for ISO 9001:2015	RMI
ISO 13485	ISO 13485 Lead Auditor Training	LAF
ISO 13485	ISO 13485 Internal Auditor Training	IAF
ISO 13485	ISO 13485:2016 Medical Device QMS Transition Training	TNF
ISO 13485	Understanding an ISO 13485 Quality Management System	QSF
ISO 13485	QMS Training for Medical Devices: FDA QSR and ISO 13485:2016	GRF
Medical Device RA/QA
Medical Device Training	ISO 13485 Lead Auditor Training	LAF
Medical Device Training	ISO 13485 Internal Auditor Training	IAF
Medical Device Training	ISO 13485:2016 Medical Device QMS Transition Training	TNF
Medical Device Training	Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition	SAF
Medical Device Training	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
Medical Device Training	New! Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program	AMF
Medical Device Training	QMS Training for Medical Devices: FDA QSR and ISO 13485:2016	GRF
Medical Device Training	Updated! ISO 14971 Medical Device Risk Management Training	RMF
Medical Device Training	Medical Device Supplier Quality Management Training	SQF
Medical Device Training	Updated! Medical Device Vigilance Training: Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management	CHF
Medical Device Training	US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training	WSF
Medical Device Training	Design Control Training for Medical Devices: Requirements and Best Practices	DBF
Medical Device Training	Process Validation Training for Medical Devices: Principles and Protocols	PVF
Medical Device Training	Optimizing CAPA Programs for the Medical Device Industry Training	CAF
Medical Device Training	Updated! SOP Writing and Process Mapping for Medical Device Regulations (ISO 13485, MDSAP and EU MDR 2017/745)	DOF
Medical Device Training	Root Cause Analysis for Life Science Investigations Training	RCF
Medical Device Training	Understanding FDA’s Medical Device Quality System Regulation	MGF
Medical Device Training	Calibration Requirements and Equipment Controls for Medical Devices	CBF
Medical Device Training	Updated! Medical Device Software Verification and Validation Requirements Training	SVF
Medical Device Training	Applied Statistics for the Workplace - Advanced	DLS
Medical Device Training	Applied Statistics for the Workplace – Intermediate	ILS
Medical Device Training	Applied Statistics for the Workplace – Level 1	BLS
Medical Device Training	Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality	PBF
ISO 13485 Training & Consulting	ISO 13485 Lead Auditor Training	LAF
ISO 13485 Training & Consulting	ISO 13485 Internal Auditor Training	IAF
ISO 13485 Training & Consulting	ISO 13485:2016 Medical Device QMS Transition Training	TNF
ISO 13485 Training & Consulting	Understanding an ISO 13485 Quality Management System	QSF
ISO 13485 Training & Consulting	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
ISO 13485 Training & Consulting	QMS Training for Medical Devices: FDA QSR and ISO 13485:2016	GRF
ISO 13485 Training & Consulting	Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality	PBF
Transition to ISO 13485:2016	ISO 13485:2016 Medical Device QMS Transition Training	TNF
FDA and Canada MDSAP Audit Certification Consulting	Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition	SAF
EU MDR (2017/745) Medical Device Compliance Consulting	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
FDA and Canada MDSAP Audit Certification Consulting	New! Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program	AMF
FDA 510(k) Submissions	US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training	WSF
Clinical Evaluation Report (CER) Development & Transition Support	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
FDA Premarket Approval (PMA) Application Medical Devices	US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training	WSF
CAPA Program Support	Updated! Medical Device Vigilance Training: Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management	CHF
CAPA Program Support	Optimizing CAPA Programs for the Medical Device Industry Training	CAF
CAPA Program Support	Root Cause Analysis for Life Science Investigations Training	RCF
ISO 14971:2012 - Medical Device Risk Management Consultants	Updated! ISO 14971 Medical Device Risk Management Training	RMF
CE Mark For Medical Devices	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
CE Mark For Medical Devices	QMS Training for Medical Devices: FDA QSR and ISO 13485:2016	GRF
CE Mark For Medical Devices	US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training	WSF

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