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Medical Device Training

Oriel STAT A MATRIX offers life sciences organizations a complete curriculum of Medical Device Training Courses that covers accredited training for auditor development, the key medical device sector regulations, as well as the processes and systems needed to comply with these regulations. 

Medical Device Training

Focused training – combined with consulting, coaching, and guidance to support your internal resources - ensures that your organization fully understands the regulations and has the necessary tools to drive business improvement. We offer the following: 

A comprehensive curriculum.

Basic FDA training courses through advanced medical device training courses in quality assurance, regulatory compliance, and accredited training for auditor development. 

Hands-on learning.

Our medical device training courses use the approach proven most effective for adult learners – interaction through simulations, exercises, and workshops. Your employees will be able to use what they learned as soon as they return to work.

Convenience.

Medical device training courses are held throughout the US as public open-enrollment seminars or as private on-site training programs tailored specifically for your company.

Learn with an industry leader in life sciences compliance.

Founded in 1968, Oriel STAT A MATRIX has more than four decades of experience helping medical device, pharmaceutical, and biotechnology manufacturers improve performance, achieve regulatory compliance, and secure sustainable results.

In 1977, the FDA chose Oriel STAT A MATRIX to work with the agency to train their investigators in the new draft Good Manufacturing Practice (GMP) regulation, the precursor to the current cGMP/Quality System Regulations (QSR). Oriel STAT A MATRIX worked with FDA to refine the GMP regulations while completing the training of the investigators. Since then, we’ve trained tens of thousands of people in this regulation, as well as subsequent versions, and assisted thousands of organizations in achieving compliance to these regulations.  Find a course.

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
Updated!   Transition to ISO 13485:2016
New!   Transition to the Medical Device Single Audit Program (MDSAP)
New!   Transition to the New EU Medical Device Regulation (MDR)
Risk Management for Medical Devices: ISO 14971
Updated!   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
Understanding FDA’s Medical Device Quality System Regulation
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
New!   Performance-Based Auditing for Medical Devices
A Tool for FDA’s Case for Quality

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.

Learn key changes in ISO 13485:2016 and prepare for your ISO 13485:2016 upgrade audit with this course. 

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

In this new 2-day course you will learn about the new requirements in the MDR and how to plan an efficient transition. 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.

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.

Understand the requirements of FDA's Quality System Regulation. 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.

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.

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