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Consulting & Auditing

Medical Device RA/QA

Medical device regulatory and QMS 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, implement an effective and compliant Quality Management System (QMS), and meet compliance and business goals throughout the products life cycle.


Medical Device RA/QA Consulting

From pre-market through a products commercialization, our regulatory affairs and quality assurance 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.

Training Courses

Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.

Course Name Public Private
ISO 13485 Lead Auditor Training Course
EU MDR Auditor Training Course (Europe’s Medical Device Regulation 2017/745)
EU MDR 2017/745 Implementation Training Course
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
QMS Training for Medical Devices: FDA QSR and ISO 13485:2016
Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366
EU IVDR Auditor Training
Inspection and Audit Readiness Training for Medical Device Manufacturers
ISO 14971 Medical Device Risk Management Training
ISO 14971:2019 Update Training
Medical Device Non-Product Software Validation Training
CER (Clinical Evaluation Report) Training for EU MDR Compliance
Conducting Remote Medical Device QMS Audit Training
Medical Device Cybersecurity Risk Management Standards & Regulations Training Course
Medical Device Software Development, Verification, and Validation Training (IEC 62304 and ISO 13485:2016)
Combination Product Device Supplier Management Training
Managing Risks in Combination Products and Drug Delivery Systems
Medical Device Software Regulations and Standards Training
Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance Training
Medical Device Complaint Handling, Event Reporting, and Recall Management Training
Medical Device Postmarket Surveillance (PMS) Program Implementation Training
Design Control Training for Medical Devices: Requirements and Best Practices
CAPA and Root Cause Investigation Training for Medical Devices
Combination Products: From Regulatory Strategy to Postmarket Surveillance
Medical Device Software Development Life Cycle Training
QMS Software Validation Training for Medical Device Companies Meeting FDA and ISO 13485 Requirements
Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746)
Process Validation Training for Medical Devices: Principles and Protocols
Medical Device Supplier Quality Management Training
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Implementation
Medical Device CAPA Training: Optimizing Your Programs
Medical Device Root Cause Analysis Training Course
US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training
ISO 13485 Internal Auditor Training
SOP Writing and Process Mapping for Medical Device Regulations
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
Understanding FDA’s Medical Device Quality System Regulation

Learn the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Click to learn more.

Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.

Learn how to implement EU MDR requirements and pass your Notified Body audits.

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

Understand the basic requirements of FDA’s QSR and ISO 13485:2016 - “QMS 101”. Click to learn more.

Learn what it takes to meet usability requirements of IEC 62366, and understand how they relate to ISO 13485, ISO 14971, EU MDR/IVDR, and FDA.
For experienced auditors who need to perform internal and supplier audits to the EU IVDR requirements.

Learn how to effectively set up a front room/back room audit approach so you are ready for FDA and NB audits/inspections.

ISO 14971:2019 and and ISO/TR 24971 have been released. Get up to speed on how to keep your risk management process state of the art. Click to learn more.

Get an in-depth review of what is different in ISO 14971:2019 and ISO/TR 24971:2020, and how to update your risk management system to align with the changes. Click to learn more.

Learn how to implement a non-product software validation program for medical devices that meets FDA and ISO 13485 requirements.

Learn all aspects of clinical evaluation from planning to postmarket clinical follow-up so your CERs can withstand Notified Body scrutiny. Click to learn more.

Learn how to audit effectively in a remote context us1/ing Information and Communication Technology.  For experienced auditors.

If your company makes connected devices, you know cybersecurity is paramount. Click to learn more.

Learn how to apply US and international regulatory requirements and standards for the design and validation of medical device software. Click to learn more.

This course will provide your organization with the knowledge and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system for your combination product. As part of this course, you will identify recommendations for writing quality agreements with contract manufacturing organizations (CMOs) and auditing.


Learn how to apply ISO 14971:2019 and ICH Q9 risk management from both a combination product focus and a process focus.

This course provides a foundation for understanding the regulatory landscape for software development. 

Make sure your organization's electronic records meet US 21 CFR Part 11 requirements. 

Learn how to increase effectiveness and efficiency throughout the complaint-handling process.

Understand how to implement a PMS process aligned with ISO/TR 20416:2020 that meets EU MDR, EU IVDR, and MDSAP requirements.


The process of design control - from establishing and verifying inputs to managing change. Click to learn more.

Learn the elements of an effective CAPA program, and how to identify and solve problems with RC tools.
Receive an overview of combination products and explore the regulatory challenges of a product that combines a medical device with a drug and/or biologic. 

This course provides an in-depth look at the software development life cycle, using the IEC 62304:2006 as a basis for the course discussions

Obtain knowledge and practical application experience needed for validating software for use in medical device quality management systems. 

Learn key changes between IVDD and IVDR, discusses how to make the transition or implement the regulation, learn best practices for implementation. 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.

Best practices and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system. 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.

Learn the elements of an effective CAPA program and best practices for optimizing your program. Click to learn more.

How to identify and solve problems with RC tools. Focus is on practice application and creating a problem-solving culture. 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.

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

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

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

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

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