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Medical Device RA/QA

Oriel STAT A MATRIX’s life cycle approach to Medical Device Regulatory Affairs and Quality Assurance (RA/QA) helps you establish systems that will ensure compliance as well as improve efficiency and productivity.

Medical Device RA/QA Consulting

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 Regulations (QSR). Since then we've been helping life science organizations to integrate compliance activities with performance improvement processes throughout the product life cycle, from initial concept, development, and commercialization through postmarket management.

Our medical device experts can help your company:

Develop a compliant quality system

Get your product to market

Manage your quality system and sustain compliance

Respond to enforcement actions

Improve performance without compromising regulatory compliance

Medical Device RA/QA Training

Oriel STAT A MATRIX offers hundreds of classes on FDA regulatory compliance and medical device-related topics in dozens of cities around the United States and in Costa Rica, as well as Professional Certificate Programs.

We can customize any course for your company and bring it to a location of your choice. For groups of five or more, these on-site classes are a cost-effective, flexible way to train your employees.

Questions? Please contact us to find out more about our medical device RA/QA services.

Select a course below to learn more or to register.
 
Course Name Public On-site
ISO 13485 Lead Auditor Training
ISO 13485 Internal Auditor Training
New!   Transition to ISO 13485:2016
Advanced Lead Auditor Training
Statistics for Lead Auditors
Global Product Submissions: FDA and EU Directive Requirements [510(k), PMA, CE Mark]
Quality Systems for Medical Devices: FDA’s QSR and ISO 13485
Supplier Quality Management: Designing a Successful Program
Updated!   Complaint Handling, Vigilance Reporting, and Recall Management: From Compliance to Best Practices
Updated!   ISO 14971: Introduction to Risk Management Across the Medical Device Product Life Cycle
Implementing Design Control Requirements and Best Practices for Medical Devices
Process Validation Principles and Protocols
Optimizing CAPA Programs for the Medical Device Industry
Developing and Maintaining a Compliant Document Management System
Root Cause Analysis for Life Science Investigations
Calibration Requirements and Equipment Controls for
Medical Devices
Updated!   Software Verification and Validation Requirements
Sterilization Planning for Medical Devices
Introduction to Process Validation
New!   Applied Statistics for the Workplace - Advanced
New!   Applied Statistics for the Workplace – Intermediate
New!   Applied Statistics for the Workplace – Level 1

This interactive course covers ISO 13485 and gives you the relevant skills and knowledge you need to carry out audits of Quality Management Systems for Medical Devices (QMS). Includes an introduction to ISO 13485:2016. 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. Includes an introduction to ISO 1385:2016. Click to learn more.

Get up to date with the changes and how they impact your organization.

Learn the skills and knowledge required for a performance-based approach to auditing that will help your organization meet its strategic goals and make your audit program the catalyst for tangible improvement to your organization’s bottom line. 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.

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. 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. Includes coverage of ISO 13485:2016. 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.

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. 

This course covers ISO 14971:2012 (and key distinctions from the 2007 version) and the application of risk management practices throughout a product's full life cycle. Includes coverage of ISO 13485:2016. Click to learn more.

Learn how to control the design process to ensure that your organization’s devices meet user needs. 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.

Corrective and preventive action (CAPA)  requirements in FDA-regulated environments can be confusing and difficult to implement.  Learn now to not only meet current and future regulations, but how these regulations can be implemented to be effective and profitable for your company. 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.

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.

This practical course will help you understand and interpret applicable calibration requirements and equipment controls for medical device manufacturers, and to understand what compliance means for your organization. Click to learn more.

Learn the fundamentals of software verification and validation, including FDA and ISO 13485 requirements. Click to learn more.

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

Acquire the skills to apply advanced statistical procedures that are relevant to assessing cause-and-effect relationships between multiple process variables, characterizing processes, and improving process performance. Click to learn more.

Acquire the skills to apply intermediate-level statistical procedures that are relevant to assessing process stability, determining process capability, and verifying cause-and-effect relationships between variables that impact process performance. Click to learn more.

Acquire the skills to apply foundational statistical procedures that are relevant to monitoring and measuring process performance.Click to learn more.