Loading ...

ISO 13485 Training & Consulting

Achieve and sustain ISO 13485 certification with training and consulting from

ISO 13485 is the harmonized quality system standard for medical device manufacturers, their suppliers, and other third parties that provide products or product components, including quality management system (QMS)-related services for the company.

Certification to ISO 13485 is the most common path to meet quality system requirements to sell your medical device outside the US (e.g., in the EU, Japan, etc.), and the Medical Device Single Audit Program (MDSAP) audit model covers the requirements of ISO 13485 plus Current Good Manufacturing Practice (cGMP) requirements for each applicable regulatory authority.

A revised ISO 13485 (ISO 13485:2016) was published on February 25, 2016.

The end of the transition period for updating certificates to the new version is March 1, 2019. If you are seeking first-time certification to ISO 13485, you should implement this version. Learn more about ISO 13485:2016.

Oriel STAT A MATRIX’s global team of qualified ISO 13485 consultants can help you:

Why Choose Oriel STAT A MATRIX

Oriel STAT A MATRIX has been helping organizations achieve regulatory compliance since 1968.

We have trained more than 130,000 auditors and have assisted hundreds of organizations regulated by FDA and global regulatory agencies to attain certification to internationally recognized standards such as FDA’s QSR, ISO 13485 and ISO 9001. We have consultants in 33 states and more than 20 countries, and our team has assisted customers in more than 75 countries.

By choosing Oriel STAT A MATRIX, you benefit from our experience as a worldwide consultant in quality management and business process improvement. We do not simply conduct ISO 13485 training and consulting; we also show you how to implement the standard as an integral tool to improve your efficiency, productivity, and profitability.

Select a course below to learn more or to register.
Course Name Public On-site
Updated!   ISO 13485 Lead Auditor Training
Understanding an ISO 13485 Quality Management System
New!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)
QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016
ISO 13485 Internal Auditor Training
ISO 13485:2016 Medical Device QMS Transition 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.

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.

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

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