How to get ISO 13485 certified? (Quality Management System)

Medical Device made Easy Podcast · May 18, 2020

In this episode of the Medical Device made Easy Podcast, I wanted to answer a recurring question I receive with as much detail as possible. The question is: “How to get ISO 13485 certified?”

As Easy Medical Device is a consulting agency helping Medical Device manufacturers to place compliant medical devices on the market, most of our clients have no experience in the Medical Device Regulations.

So in this video, I will answer this question.

AGENDA

What is ISO 13485?

Who can provide this certificate?

How much does it cost to get ISO 13485 certified?

Frequency of the audits

What…