Medical Device RA/QA

 

Oriel STAT A MATRIX can help organizations in every phase of the medical device life cycle: premarket, product realization, and postmarket.

Since 1978, our experienced consultants have assisted medical device and in vitro diagnostic product manufacturers at every step, from achieving compliance with FDA regulations to making processes more effective and efficient, thus improving business performance.

Typically, our medical device compliance and quality training and consulting services include:

In addition to providing directed consulting services, we offer a comprehensive suite of medical device, ISO 13485 and FDA training courses. These courses are held regularly in more than 40 cities across the United States; they can also be presented at a location of your choice. All of our courses can be customized for your organization.
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
Auditor/Lead Auditor Training for ISO 13485
CAPA Programs for the Medical Device Industry
CE Marking, EU Directives, and Guidance Documents
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 ISO 13485 Quality Management Systems
Introduction to Process Validation
Process Validation Principles and Protocols
Risk Management and Analysis for Medical Devices
Software Verification and Validation Requirements
Sterilization Planning for Medical Devices
Understanding an ISO 13485 Quality Management System
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.

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.

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.

Improve your sales and increase customer satisfaction with medical devices that bear the CE Mark, allowing them to be legally sold within the European Union (EU). 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.

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.

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.

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.

Get the information you need to understand the ISO 13485:2003 and ISO 9001 standards and how they impact your organization. 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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