Certifying to ISO 13485 and Global Medical Devices Regulatory Requirements - MDSAP

by John Pappachan published on June 26, 2020

The MDSAP is growing in popularity in the medical devices industry. Many organizations are choosing MDSAP especially if they sell products in multiple countries. MDSAP allows organizations to get one audit of their quality management system by an approved auditing organization (3rd Party) using approved auditors. The audit, if successful, will result in the organization being approved in multiple jurisdictions including Australia, Brazil, Canada, Japan, and the United States.

Omnex recommends an ISO 13485 management system with integrated regulatory requirements of Australia, Brazil, Canada, Japan and the United States. Watch this important webinar recording for medical device organizations as we explain the MDSAP Framework, process approach, and the primary and supporting processes.


Watch this first webinar recording in a series of three for our medical device customers – 

1) Why MDSAP? 

2) Best In Class Medical Device Systems for MDSAP (Omnex’s experience in achieving Zero Defects) and 

3) Software Management Systems for Medical Devices.