Medical Device RA/QA

Oriel STAT A MATRIX helps you establish systems that will ensure compliance as well as improve efficiency and productivity.

View Medical Device RA/QA Courses

Since 1968, Oriel STAT A MATRIX has helped medical device, pharmaceutical, and biotechnology manufacturers achieve compliance with FDA regulations and international medical device regulations while improving business processes, thus reducing both cost and risk.

Whether the scope of your consulting needs includes implementing a compliant quality management system, obtaining 510(k) premarket notification clearance, or preparing an effective response to an FDA 483 or Warning Letter, Oriel STAT A MATRIX’s team of medical device industry experts and former FDA officials will efficiently and effectively guide you through the necessary steps.

We can also help you develop your in-house expertise with our full range of Medical Device RA/QA training courses. Courses are available in cities across the United States and Costa Rica. All of our courses can also be customized for your unique needs and presented at any location of your choice.

Our medical devices, combination products, and in vitro diagnostics (IVD)  compliance and quality training and consulting services include:

Our standard training courses include those listed below. Click on any course title for more information.
 
Course Name Public On-site
Advanced Lead Auditor Training
Course Combo: Design Control Concepts and Implementation and Risk Management and Analysis for Medical Devices
Course Combo: Implementing CAPA Programs for the Medical Device Industry and Root Cause Analysis for Life Science Investigations
Course Combo: Internal Auditor Training for ISO 13485 and Developing and Maintaining a Compliant Document Management System
Design Control Concepts and Implementation
Developing and Maintaining a Compliant Document Management System
Global Product Submissions: FDA and EU Directive Requirements [510(k), PMA, CE Mark]
Implementing a Complaint-Handling and Recall Program
Implementing CAPA Programs for the Medical Device Industry
Introduction to ISO 13485 Quality Management Systems
Introduction to Process Validation
ISO 13485 Internal Auditor Training
ISO 13485 Lead Auditor Training
Process Validation Principles and Protocols
Quality Systems for Medical Devices: FDA’s QSR and ISO 13485
Risk Management and Analysis for Medical Devices
Root Cause Analysis for Life Science Investigations
Software Verification and Validation Requirements
Statistics for Lead Auditors
Sterilization Planning for Medical Devices
Supplier Quality Management: Designing and Implementing a Successful Program

Are your audits helping your organization meet its strategic goals? Are you looking to acquire skills to make your audit program the catalyst for tangible improvement to your organization’s bottom line? Click to learn more.

Design control is a critical area for medical device manufacturers and it is necessary that it be fully integrated with your risk management program. Learn how to accomplish this by combining our Design Control Concepts and Implementation and Risk Management and Analysis for Medical Devices courses for an integrated 4-day learning event. Click to learn more.

Fix problems once. A robust root cause analysis investigation provides clear solutions for an effective CAPA program. Combine our Implementing CAPA Programs for the Medical Device Industry course with our new Root Cause Analysis training for 5 days of intensive training. Click to learn more.

Acquire the essential tools for maintaining an ISO 13485-compliant quality system by combining our Internal Auditor for ISO 13485 course with our Developing and Maintaining a Compliant Document Management System course. 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.

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

Master the global requirements for medical device development and regulatory submissions, so your company can successfully obtain product approval and gain a competitive advantage in global markets.

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. 

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.

Understand the requirements and benefits of an ISO 13485-compliant quality management system including steps and timing for a typical implementation. 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.

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.

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.

Designed for both new and experienced professionals in the medical device field, this course will give you a solid understanding of the necessary components of an effective, compliant quality system for medical device manufacturing. 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.

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.

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.

Lead auditors - go beyond conformance with training that shows you how to use statistical knowledge to analyze process data and draw meaningful conclusions. Click to learn more.

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

Over the past five years, the regulatory bodies have increased their focus on supplier quality programs at companies due to the number of recalls and customer complaints. Click to learn more.

 

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