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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:

Obtain approval to commercialize your medical device and/or IVD in the US, EU and international markets

Develop a compliant quality system

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.

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
Transition to ISO 13485:2016
Understanding an ISO 13485 Quality Management System
New!   Transitioning to the Medical Device Single Audit Program (MDSAP)
Risk Management for Medical Devices: ISO 14971
New!   Performance-Based Auditing for Medical Devices
A Tool for FDA’s Case for Quality
Quality Systems for Medical Devices:
FDA’s QSR and ISO 13485:2016
Complaint Handling, Vigilance Reporting, and Recall Management: From Compliance to Best Practices
Supplier Quality Management: Designing a Successful Program
Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark]
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
Applied Statistics for the Workplace - Advanced
Applied Statistics for the Workplace – Intermediate
Applied Statistics for the Workplace – Level 1

Now updated for ISO 13845:2016!  This interactive course gives you the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Exercises include audit criteria from 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. Course exercises feature audit criteria from ISO 13485:2016. Click to learn more.

This course was developed by a leading member of the ISO TC/210 working group responsible for creating ISO 13485:2016. Learn key changes and how they impact your organization.

This on-site only course is for organizations in the medical device supply chain that are considering gaining ISO 13485:2016 certification or are new to ISO 13485 and want to understand the requirements. Click to learn more.

Is your company participating or considering participation in MDSAP? Our 2-day course will help you understand the program and plan a transition to MDSAP. 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.

Designed for experienced auditors. Course participants learn how to go beyond compliance and analyze the performance-related data needed to improve processes, produce higher-quality devices, and achieve better patient outcomes.

Gain a solid understanding of the necessary components of an effective, compliant quality system for medical device manufacturing. 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. 

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.

Learn about the available options for bringing a device to market in the US and/or EU. 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 how to optimize your CAPA Progam to meet requirements and improve your business. 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.

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.

Our team is here to help. Call 1.888.532.6360 or contact us online ›