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ISO 13485

Achieve and sustain ISO 13485 certification with flexible consulting and training options from Oriel STAT A MATRIX’s medical device experts.

Our flexible ISO 13485 training and consulting services can help you:

Why Choose Oriel STAT A MATRIX?

Leverage more than four decades of experience.

Founded in 1968, Oriel STAT A MATRIX has trained more than 120,000 auditors and helped hundreds of organizations regulated by FDA and global regulatory agencies achieve certification to internationally recognized standards such as ISO 9001 and ISO 13485.

Learn from an industry leader in Life Sciences compliance.

In 1978, FDA chose Oriel STAT A MATRIX 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 hundreds of organizations in achieving compliance to these regulations.

Focus on Excellence.

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 but 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
ISO 13485 Lead Auditor Training
ISO 13485 Internal Auditor Training
Understanding an ISO 13485 Quality Management System
Updated!   Transition to ISO 13485:2016
Updated!   Quality Systems for Medical Devices:
FDA’s QSR and ISO 13485:2016

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

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

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