FDA Compliance for Medical Devices > Training and Consulting

Oriel STAT A MATRIX offers hundreds of classes on FDA compliance and medical device-related topics in more than 40 cities around the United States. In addition, each of our FDA Training courses can be customized and presented at a location of your choice. For groups of five or more, on-site classes are a cost-effective, flexible, confidential way to train your employees in FDA regulations. You can trust our highly-skilled trainers to transfer the knowledge to your staff effectively and efficiently.

We also provide FDA regulatory consulting services for regulated companies in areas such as FDA 510(k) Submissions, design control, document review, process validation, software verification and validation, risk assessment and analysis, audit preparation, CE marking, and responses to FDA findings.

As well as our FDA Compliance training solutions, we offer  similar training and consulting for ISO 13485.
Our standard training courses include those listed below. Click on any course title for more information.
 
Course Name Public On-site
510(k) Process for Medical Devices
CAPA Programs for the Medical Device Industry
Course Combo: Understanding FDA's Medical Device QSR and QSIT, Understanding an ISO 13485 QMS
Design Control Concepts and Implementation
Documenting a GMP/ISO Compliant Quality System
Internal Auditor Training for ISO 13485
Introduction to Process Validation
Lead Auditor Training for ISO 13485
Process Validation Principles and Protocols
Risk Management and Analysis for Medical Devices
Software Verification and Validation Requirements
Sterilization Planning for Medical Devices
Understanding FDA’s Medical Device QSR and QSIT

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 U.S., what is needed to complete the 510(k) process, and when a 510(k) must be submitted. Click to learn more.

Corrective and Preventive Action (CAPA) requirements in FDA-regulated environments can be confusing and difficult to implement. Learn how to not only meet current and future regulations, but also how these regulations can be implemented to be effective and profitable for your company. Click to learn more.

Taken together, these 2 courses provide a comprehensive understanding of medical device quality management system requirements including ISO 13485, as well as the FDA’s Quality System Regulation (QSR) and QSIT.

In addition, take both classes together and save $200. Click to learn more.

Learn how to control the design process to assure that your organization's devices meet user needs, intended uses, and specified requirements. Click to learn more.

In this workshop-based program, learn how to approach the GMP/ISO documentation process in the most effective, efficient manner while adding value to your company’s overall quality management system. Click to learn more.

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. Click to learn more.

Using careful reviews of requirements from ISO 9001, ISO 13485 and QSR along with case studies and in-class activities, learn the fundamentals and principles of process validation. Click to learn more.

Based on our ISO 9001 RABQSA-certified QMS lead auditor training course, this interactive course covers ISO 13485 in addition to ISO 9001 requirements for quality management systems. Click to learn more.

Using careful reviews of requirements from ISO 9001, ISO 13485 and QSR along with case studies and in-class activities, learn the fundamentals and principles of process validation. Click to learn more.

Get the latest information on risk management concepts and practices for the medical device industry and learn how to plan your organization's risk management and analysis program. Click to learn more.

Learn the fundamentals required to understand how ISO 9001, ISO 13485, and FDA’s Quality System Regulation (QSR) apply to verification and validation of computerized systems. Click to learn more.

Understand the difference between EtO, gamma, and other sterilization methods and their effects on medical devices. Click to learn more.

Can your organization survive an FDA inspection? Are you aware of all of the different aspects of your business that FDA will be inspecting? Click to learn more.

 

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