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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.

Overview

Overview

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 goal: to establish systems that not only comply with regulations but also continually improve business processes.

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

Find medical device regulatory compliance training courses for beginners through experts. 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
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
Complaint-Handling and Recall Management: Maintaining a Compliant Program
ISO 14971: Risk Management and Analysis for Medical Devices
Implementing Design Control Requirements and Best Practices
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
Software Verification and Validation Requirements
Sterilization Planning for Medical Devices
Introduction to Process Validation
Course Combo: Implementing Design Control Requirements and Best Practices and ISO 14971: Risk Management and Analysis for Medical Devices
Course Combo: Optimizing CAPA Programs for the Medical Device Industry and Root Cause Analysis for Life Science Investigations

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. 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 now 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. Click to lean more.

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

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 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.

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.

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 Implementing Design Control Requirements and Best Practices and Implementation and Risk Management and Analysis for Medical Devices courses for an integrated 5-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.

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Global Headquarters: Edison, NJ
One Quality Place
Edison, NJ 08820
Phone: 1.888.532.6360
Fax: 732.548.4085

  • International Offices:

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