Maximizing your Certification to ISO 13485

ISO 13485:2016 offers medical device manufacturers a quality management system that translated into greater consistency, improved quality and less risk.

The central principle within the standard, as with other recent updated ISO standards, is risk-based thinking throughout the medical device lifecycle.

With the transition period now complete there are a number of lessons learned, including:

  • How to maintain an effective ISO 13485:2016 QMS after upgrading
  • How to plan and address your internal and external non-conformities

In this webinar, we’ll also review practical examples for the validation of software used in quality management systems and Quality Agreements with suppliers.


Learn more about the ISO 13485:2016 medical devices standard here.

Or, contact us to see how SAI Global has helped organizations like yours.

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8 Factors to Prepare for your MDSAP Audit
8 Factors to Prepare for your MDSAP Audit

The Medical Device Single Audit Program, or MDSAP, is a program that allows medical device manufacturers to...

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Preparing for a Successful Implementation of the Medical Device Single Audit Program
Preparing for a Successful Implementation of the Medical Device Single Audit Program

During this webinar, we’ll review an MDSAP audit from the perspe.ctive of an MDSAP Auditor

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