FDA Training Courses - Medical Device Training Courses

Medical Device Training

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

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 60 days of RA/QA training content available:
- Certified auditor training options for ISO 9001, ISO 13485, EU Medical Device Regulation, 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 ~$1M 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.
On-Site Training: Need to train a group? We’ll deliver the class as-is or tailored to the needs of your personnel.
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.
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.

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
EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
QMS Training for Medical Devices: FDA QSR and ISO 13485:2016
New! EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746)
ISO 14971 Medical Device Risk Management Training
New! ISO 14971:2019 Update Training
New! CER (Clinical Evaluation Report) Training for EU MDR Compliance
New! Conducting a Remote Medical Device QMS Audit
Medical Device Software Development, Verification, and Validation Training
New! Medical Device Cybersecurity Risk Management Training
New! FDA 21 CFR Part 11 – Electronic Records Training for Medical Device Companies
Medical Device Complaint Management and Vigilance Training
Design Control Training for Medical Devices: Requirements and Best Practices
New! QMS Software Validation Training for Medical Device Companies
New! Implementing the EU's New In Vitro Diagnostic Regulation Training (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 Transition
Medical Device CAPA Training: Optimizing Your Programs
Medical Device Root Cause Analysis Training
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 (ISO 13485, MDSAP and EU MDR 2017/745)
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 the latest in EU MDR interpretation gleaned from our work with Notified Bodies, EU thought leaders, and device organizations making the 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.

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

For experienced auditors who need to perform internal and supplier audits to the EU IVDR 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.

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

This class is for experienced medical device auditors who want to learn how to conduct effective remote audits.

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

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

Make sure your organization's Electronic Records meet US 21 CFR Part 11 requirements.

Understand the global requirements for complaint handling and event reporting with a focus on the US, EU and the new EU MDR, and MDSAP countries. Click to learn more.

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

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.

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

Get answers right now. Call 1.800.472.6477