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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
Medical Device RA/QA
Medical Device Training	Updated! ISO 13485 Lead Auditor Training	LAF
Medical Device Training	New! CER (Clinical Evaluation Report) Training for EU MDR Compliance	ECF
Medical Device Training	New! EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)	LEF
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	New! EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)	EIF
Medical Device Training	Updated! ISO 14971 Medical Device Risk Management Training	RMF
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	Updated! Medical Device Complaint Management and Vigilance Training	CHF
Medical Device Training	Updated! Medical Device Supplier Quality Management Training	SQF
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	Medical Device CAPA Training: Optimizing Your Programs	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	Medical Device Root Cause Analysis 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 Development, Verification, and Validation Training	SVF
Medical Device Training	Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality	PBF
ISO 13485 Training & Consulting	Updated! ISO 13485 Lead Auditor Training	LAF
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	ISO 13485 Internal Auditor Training	IAF
ISO 13485 Training & Consulting	ISO 13485:2016 Medical Device QMS Transition Training	TNF
ISO 13485 Training & Consulting	Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality	PBF
ISO 13485:2016 Transition	ISO 13485:2016 Medical Device QMS Transition Training	TNF
EU MDR (2017/745) Consulting	New! CER (Clinical Evaluation Report) Training for EU MDR Compliance	ECF
EU MDR (2017/745) Consulting	New! EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)	LEF
EU MDR (2017/745) Consulting	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
MDSAP Auditing	New! Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program	AMF
EU MDR (2017/745) Consulting	New! EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)	EIF
MDSAP Auditing	Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition	SAF
EU IVDR (2017/746) Consulting	New! EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)	EIF
US FDA 510(k)	US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training	WSF
EU CER & MEDDEV 2.7/1	New! CER (Clinical Evaluation Report) Training for EU MDR Compliance	ECF
EU CER & MEDDEV 2.7/1	New! EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)	LEF
EU CER & MEDDEV 2.7/1	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
US FDA PMA Submission	US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training	WSF
CAPA Process Consulting	Updated! Medical Device Complaint Management and Vigilance Training	CHF
CAPA Process Consulting	Medical Device CAPA Training: Optimizing Your Programs	CAF
CAPA Process Consulting	Medical Device Root Cause Analysis Training	RCF
ISO 14971 & Risk Management	Updated! ISO 14971 Medical Device Risk Management Training	RMF
EU CE Marking Certification	New! EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)	LEF
EU CE Marking Certification	New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)	EMF
EU CE Marking Certification	QMS Training for Medical Devices: FDA QSR and ISO 13485:2016	GRF
EU CE Marking Certification	New! EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)	EIF
EU CE Marking Certification	US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training	WSF
ISO 9000 & Related Standards
ISO 9001	ISO 9001 Lead Auditor Training	LAI
ISO 9001	ISO 9001 Internal Auditor Training	IAI
ISO 13485	Updated! ISO 13485 Lead Auditor Training	LAF
ISO 13485	Understanding an ISO 13485 Quality Management System	QSF
ISO 13485	QMS Training for Medical Devices: FDA QSR and ISO 13485:2016	GRF
ISO 13485	ISO 13485 Internal Auditor Training	IAF
ISO 13485	ISO 13485:2016 Medical Device QMS Transition Training	TNF
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
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
Voice of the Customer	Listening to the Voice of the Customer	VC3

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