Episode 12 – How to create an ISO Standard with Marcelo Antunes

Medical Device made Easy Podcast · Feb 25, 2019

Episode 12 – ISO Standards Creation with Marcelo Antunes

On the Medical Device made Easy Podcast I invited Marcelo Antunes from SQR Consulting to help us understand how the ISO standards we are using are created. Do you know how ISO 13485, ISO 14971 are created? Who is deciding which rules to apply? Are you also angry because some of the requirements doesn’t make sense?

Marcelo Antunes will tell us everything. You’ll know how to create standards and also how YOU can participate in the creation of a Standard which is really important for manufacturers.

We will also discuss…