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Medical Device RA/QA

Medical device regulatory consulting support spans pre-market, manufacturing and post-market – ensuring you get your medical device and/or IVD to market as quickly and cost effectively as possible and meet compliance and business goals throughout the products life cycle.

Medical Device Regulatory Consulting

From pre-market through a products commercialization, our regulatory affairs experts collaborate with Device and IVD manufactures across the globe to:

Why choose Oriel STAT A MATRIX?

In 1977, FDA chose Oriel STAT A MATRIX to work with the agency to train their investigators in the new draft Good Manufacturing Practice (GMP) regulations, the precursor to the current cGMP/Quality System Regulation (QSR).  Since then, we’ve developed the experience needed to support medical device manufacturers at every step – from achieving compliance with FDA and global regulations to making processes more effective and efficient to improve business results.

Select a course below to learn more or to register.
Course Name Public On-site
ISO 13485 Lead Auditor Training
ISO 13485 Internal Auditor Training
ISO 13485:2016 Medical Device QMS Transition Training
Understanding an ISO 13485 Quality Management System
Medical Device Single Audit Program (MDSAP) Training:
Preparing for a Successful Transition
New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)
New!   Internal Auditing to MDSAP:
Concepts and Practices in Aligning the Internal Audit Program
QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
Updated!   ISO 14971 Medical Device Risk Management Training
Updated!   Medical Device Supplier Quality Management Training
Updated!   Medical Device Vigilance Training:
Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management
US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training
Design Control Training for Medical Devices:
Requirements and Best Practices
Process Validation Training for Medical Devices:
Principles and Protocols
Optimizing CAPA Programs for the Medical Device Industry Training
Updated!   SOP Writing and Process Mapping for Medical Device Regulations
(ISO 13485, MDSAP and EU MDR 2017/745)
Root Cause Analysis for Life Science Investigations Training
Understanding FDA’s Medical Device Quality System Regulation
Calibration Requirements and Equipment Controls for
Medical Devices
Updated!   Medical Device Software Verification and Validation Requirements Training
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

This interactive course gives you the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Exercises include audit criteria from ISO 13485:2016. Click to learn more.

Exemplar Global Certified QMS Internal Auditor Training Course. Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. Course exercises feature audit criteria from ISO 13485:2016. Click to learn more.

Learn key changes in ISO 13485:2016 and prepare for your ISO 13485:2016 upgrade audit with this course. 

This course is for organizations in the medical device supply chain that are considering gaining ISO 13485:2016 certification or are new to ISO 13485 and want to understand the requirements. Click to learn more.

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

In this new course you will learn about the new requirements in the MDR and how to plan an efficient transition. Click to learn more.

Designed for experienced auditors, this intensive class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.

Gain a solid understanding of the necessary components of an effective, compliant quality system for medical device manufacturing. Click to learn more.

This course covers ISO 14971 and the application of risk management practices throughout a product's full life cycle. Click to learn more.

Poorly designed and executed supplier quality management systems can cost your company millions. This course will provide your organization with the knowledge to design a comprehensive medical device supplier quality management system to comply with US and international regulations. Click to learn more.

This course will give your organization the key tools for establishing a robust process for the initial intake and triage of customer complaints and any subsequent global regulatory reporting, whether an individual case (MDR, vigilance report) or a correction/removal to ensure product quality and/or safety. Click to learn more. 

Learn how to identify an appropriate regulatory pathway to obtain product approval or clearance in the United States and/or the European Union (EU). Click to learn more.

Learn how to control the design process to ensure that your organization’s devices meet user needs. Click to learn more.

FDA and ISO 13485 both require process validation, but they do not offer much guidance. Get the how-to’s in our updated course Process Validation Principles and Protocols. This class features hands-on workshops to ensure you can transfer what you learn to your workplace.

Corrective and preventive action (CAPA) requirements in FDA-regulated environments can be confusing and difficult to implement.  Learn how to optimize your CAPA Progam to meet requirements and improve your business. Click to learn more.

Learn how to effectively and efficiently handle the cGMP/ISO document control requirements in this workshop-based program. Click to learn more.

This course will help you master the entire root cause analysis process, from accurately identifying the root cause of a problem to designing an effective intervention. This practical course goes beyond theory to teach you specific steps and tools so you can immediately apply what you learn. Click to learn more.

Understand the requirements of FDA's Quality System Regulation. Click to learn more.

This practical course will help you understand and interpret applicable calibration requirements and equipment controls for medical device manufacturers, and to understand what compliance means for your organization. Click to learn more.

Learn the fundamentals of software verification and validation, including FDA and ISO 13485 requirements. Click to learn more.

Designed for experienced auditors. Course participants learn how to go beyond compliance and analyze the performance-related data needed to improve processes, produce higher-quality devices, and achieve better patient outcomes.

Get answers right now. Call 1.888.532.6360