Transition to the New EU Medical Device Regulation (MDR)

The MDR brings major changes to premarket and postmarket requirements for medical devices in the EU.


Stay ahead of fast-moving medical device regulatory changes.

Choose from one of 19 classes – offered in 12 US cities – each taught by experienced instructors in an unmatched hands-on format that’s been fine-tuned over 50 years


Transition to the Medical Device Single Audit Program (MDSAP)

Canada will require MDSAP certification by January 2019.


The deadline to transition to
ISO 13485:2016 is March 2019.

Make sure you are prepared.


Get to know us...

Since 1968, Oriel STAT A MATRIX has provided organizations with the business process management tools they need to meet global regulatory requirements, increase quality, efficiency, and profitability. Whether you are beginning a new performance improvement initiative or expanding an existing one,

Oriel STAT A MATRIX provides best-in-class performance improvement training and consulting solutions - including FDA-regulated services, implementation of ISO 9000, and continual improvement methods such as Lean Six Sigma - that enhance financial results and customer satisfaction. LEARN MORE

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