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QA/RA Consulting, Auditing & Training

Medical Device RA/QA

Medical Device Training

Medical Device Training Classes: Open Enrollment, or Private. Online and In-Person.

Overview

Your company’s effectiveness depends on your employees’ skills and knowledge. For medical device manufacturers, employee training is also required to satisfy FDA and international regulatory requirements.

Your training provider needs to know the medical device sector, how to create effective training for adults, and have an extensive portfolio of courses

Since 1968, Oriel STAT A MATRIX has delivered RA/QA training to medical device manufacturers around the globe.

91% of the largest medical device manufacturers rely on Oriel STAT A MATRIX for their RA/QA training
130,000+ RA/QA professionals trained (so far!)
More than 95 days of RA/QA training content available:
- Certified auditor training options for ISO 9001, ISO 13485, EU MDR, EU IVDR, and MDSAP
- Updated course contents to reflect current global regulations
Instructors with 15+ years of practical industry experience
Flexible delivery and licensing options

What distinguishes our training?

All our classes are designed by an experienced team of subject matter experts and instructional designers.

Optimized Course Design

Each Oriel STAT A MATRIX course emphasizes interactivity and hands-on workshops - the approach proven most successful for adult learners.

Experienced Instructors

Our classes are taught by former regulatory and quality professionals who average 15+ years of real-world experience and all share a demonstrated ability to teach effectively and keep the classroom lively and varied.

State-of-the-Art Content

Each year Oriel STAT A MATRIX invests significantly to develop and maintain our training content and professional training staff . Benefit from our investment to ensure that your training investment yields a positive return.

Flexible delivery options.

Get the training you need – how, where, and when you want it.

Public Training: Our RA/QA classes are offered in convenient locations across the US and in Costa Rica, totaling 300+ sessions to choose from each year.
Private Training: Need to train a group? We’ll deliver the class as-is or tailored to the needs of your personnel. know more >>
Online, Virtual Instructor-Led Training: An ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.
Course Customization: Oriel STAT A MATRIX’s existing courses can be customized to meet your organization’s specific business needs. This often includes integrating customer specific examples, case studies, or workshops into the training.
eLearning Licensing and Program Development - We offers a library of foundational eLearning modules covering basic RA/QA topics, standards, and regulations. These materials can be purchased for enterprise-wide licenses. Many customers also choose to work with our expert design team to develop eLearning modules and programs that meet their specific goals. All content is state of the art, and we leverage our extensive learning library to ensure timely delivery. know more >>
Coaching: Our trainers can stay on-site after the training and work one-on-one with your team. During these engagements, the course instructor shifts into a coaching role, supporting the students as they apply their new skills and knowledge to real issues at the organization. This hands-on, guided practice reinforces what was taught, improving both retention and the ROI for the training.
Training Program Development: Our training professionals are available to assist your organization with assessing training needs, developing or updating your RA/QA curriculum, and designing and teaching pilot courses. Your organization owns the training assets, and we are there to help you improve and update them.
Material Licensing and Train-the-Trainer Programs: Many of our customers choose to license our training materials for use within their organization. Our team will work with you to identify your training needs and provide the right training materials to meet your organization’s requirements. Licensed materials can be delivered as-is or customized with your organization’s specific examples, relevant case studies, and/or company branding. Licensed materials include facilitation guides to support your trainers. We can also provide train-the-trainer and ongoing course updates to ensure an optimal experience for your organization.
Customized Certification Programs: Oriel STAT A MATRIX can customize formal certification programs for your organization covering subject matter areas that are critical to the medical device and life sciences industries. We designed these programs to empower you with the skills and knowledge to tackle the issues that have the greatest impact on compliance and performance.

Training is Oriel STAT A MATRIX’s core business; it is not a sideline service. Turn to our expertise to achieve the results you need. Contact us or find a class.

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
New! QMS Training for Medical Devices: ISO 13485:2016 and FDA QMSR
ISO 13485 Lead Auditor Training Course
New! Transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) - DaySmart Series
ISO 14971 Medical Device Risk Management and Analysis Training
Medical Device QMS Overview Training
Medical Device CAPA and Root Cause Investigation Training
Medical Device Design Control Training
EU MDR Auditor Training Course for Europe’s Medical Device Regulation (2017/745)
EU MDR Training for the European Medical Device Regulation (2017/745)
ISO 13485 Internal Auditor Training Class
Medical Device Single Audit Program (MDSAP) Internal Auditor Training
Medical Device Complaint Handling, Event Reporting, and Recall Management Training
EU MDR CER (Clinical Evaluation Report) Training for Medical Devices
Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training
Medical Device Supplier and Subcontractor Quality Management Training
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality
Understanding FDA’s Medical Device Quality System Regulation
New! Inspection and Audit Readiness Training for Medical Device Manufacturers
Medical Device Process Validation Training Course: FDA and ISO 13485 Requirements
Medical Device Production and QMS Software Validation Training
ISO 13485 Overview Training for Medical Device and IVD Manufacturers
ISO 9001 Internal Auditor Training
Combination Device Supplier Management Training
EU IVDR Auditor Training Class (2017/746)
Medical Device Cybersecurity Risk Management, Regulations and Standards Training
EU In Vitro Diagnostic Regulation Overview Training (IVDR 2017/746)
Medical Device Postmarket Surveillance (PMS) Training
FDA and EU Medical Device Software Regulations and Standards Training
FDA and EU Medical Device Labeling Requirements Training
Inspection and Audit Readiness Training for Medical Device Manufacturers
Inspection and Audit Readiness Training for Medical Device Manufacturers
FDA and EU Medical Device Classification and Regulatory Pathway Training
ISO 14971 and Risk Management Training for Combination Drug-Device-Biologic Products
Medical Device Single Audit Program (MDSAP) Training
FDA 21 CFR Part 11 Training: Pharmaceutical Data Integrity, ALCOA+, and Electronic Records
FDA Part 11 Compliance and Medical Device Data Integrity Training
ISO 9001:2015 Lead Auditor Training Course
Lean Six Sigma Champion Training Course
Lean Six Sigma Champion Training Course
US FDA and EU Regulatory Requirements Training for Combination Products
Design Control Training for Drug-Device and Other Combination Products
Medical Device SOP Writing and Process Mapping Training
FDA GMP Inspection and For Cause Audit Training for Combination Products
Lean Six Sigma Black Belt Certification Training
Lean Six Sigma Black Belt Certification Training
Lean Six Sigma Master Black Belt Certification Training Course
Lean Six Sigma Master Black Belt Certification Training Course
Training on How to Conduct a Remote Medical Device QMS Audit
Root Cause Analysis for Combination Products and Drug Delivery Systems
Root Cause Analysis for Combination Products and Drug Delivery Systems
Medical Device Human Factors Usability and IEC 62366 Training
Drug Delivery System Human Factors and Usability Requirements Training

Understand the basic requirements of FDA’s QMSR and the relationship with ISO 13485:2016. Click to learn more.

Learn how to implement the new FDA QMSR requirements.

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.

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

Learn the elements of an effective CAPA program, and how to identify and solve problems with RC tools.

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

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

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

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

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

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

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

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

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.

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

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.

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

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

Receive a foundation for medical device labeling in accordance with US FDA and EU requirements. 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.

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.

In this course, you will obtain the knowledge and practical application experience needed to ensure your devices and regulated IT systems maintain or exceed the high level of quality expected by FDA.

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

Do you know how to get your devices approved while avoiding common pitfalls and costly delays? Medical device companies must have FDA 510(k) approval to market products in the United States. Learn the best way to get your approval to market in the US, what is needed to complete the 510(k) process, and when a 510(k) must be submitted. Click to learn more.

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

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.

This course provides an overview of the requirements of IEC 62366-1:2020, including the relationship with the risk management process.

Related Downloads

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

	Design Control for Medical Devices 101
	Medical Device Complaint Handling 101
	Clinical Evaluation Reports 101
	Customized CAPA Training Addresses 483 Findings for a Medical Device Manufacturer
	Becoming an Effective ISO 13485:2016 Auditor 101
	Supplier Quality Management 101
	Root Cause Analysis 101
	Risk Management 101
	Medical Device Process Validation 101

Oriel STAT A MATRIX’s Goal

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

REQUEST A PROPOSAL Or ask a question!

Get answers right now. Call

US OfficeWashington DC

1.800.472.6477

EU OfficeCork, Ireland

+353 21 212 8530

Group Discount | Save up to 25%

Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free*.