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Medical Device RA/QA

Medical device regulatory and QMS consulting support spans pre-market, manufacturing and post-market – ensuring you get your medical device and/or IVD to market as quickly and cost effectively as possible, implement an effective and compliant Quality Management System (QMS), and meet compliance and business goals throughout the products life cycle.

Medical Device RA/QA Consulting

From pre-market through a products commercialization, our regulatory affairs and quality assurance experts collaborate with Device and IVD manufactures across the globe to:

Why choose Oriel STAT A MATRIX?

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 Regulation (QSR).  Since then, we’ve developed the experience needed to support medical device manufacturers at every step – from achieving compliance with FDA and global regulations to making processes more effective and efficient to improve business results.

Select a course below to learn more or to register.
 
Course Name Public On-site
ISO 13485 Lead Auditor Training
Understanding an ISO 13485 Quality Management System
New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance
EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
New!   EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
ISO 14971 Medical Device Risk Management Training
QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)
ISO 13485 Internal Auditor Training
ISO 13485:2016 Medical Device QMS Transition Training
Medical Device Complaint Management and Vigilance Training
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition
Medical Device Supplier Quality Management Training
US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training
Design Control Training for Medical Devices: Requirements and Best Practices
Process Validation Training for Medical Devices:
Principles and Protocols
Medical Device CAPA Training: Optimizing Your Programs
SOP Writing and Process Mapping for Medical Device Regulations
(ISO 13485, MDSAP and EU MDR 2017/745)
Medical Device Root Cause Analysis Training
Understanding FDA’s Medical Device Quality System Regulation
Calibration Requirements and Equipment Controls for
Medical Devices
Medical Device Software Development, Verification, and Validation Training
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Updated to reflect the revised ISO 19011:2018, the standard for auditing quality management systems. Learn the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Click to learn more.

This 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.

Learn all aspects of clinical evaluation from planning to postmarket clinical follow-up so your CERs can withstand Notified Body scrutiny. Click to learn more.

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

Designed for experienced auditors, this intensive class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.

Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.

Understand the practical application of risk management tools during the life cycle of your device. Click to learn more.

Understand the basic requirements of FDA’s QSR and ISO 13485:2016 - “QMS 101”. Click to learn more.

Learn key changes between IVDD and IVDR, discusses how to make the transition, learn best practices for transitioning. 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. 

Understand the global requirements for complaint handling and event reporting with a focus on the US, EU and the new EU MDR, and MDSAP countries. Click to learn more. 

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.

Best practices and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system. Click to learn more.

Learn how to identify an appropriate regulatory pathway to obtain product approval or clearance in the United States and/or the European Union (EU). Click to learn more.

The process of design control - from establishing and verifying inputs to managing change. 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.

Learn the elements of an effective CAPA program and best practices for optimizing your program. 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.

How to identify and solve problems with RC tools. Focus is on practice application and creating a problem-solving culture. 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 how to satisfy US and global regulatory requirements for the design and validation of software in devices. 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.

Get answers right now. Call 1.888.532.6360