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Karthik Mr
December 2019
I want to become and ISO13485 Product Realization & MDR auditor. How can get specialized in this?
< 1 min reading time

What’s the best way to achieve my goal? I’ve been Product Manager at Dentia Innovations in Bengaluru, Karnataka, India for more than three years. Do I take classes?

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Asked on December 15, 2019 9:46 pm
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Eckhard Jokisch

Hi Kartik,
for becoming an MDR auditor you need to join one of the MDR Notified Bodies. The professional requirements are differing from NB to NB. Best to ask them.

Becoming an 13485 auditor depends a lot of your knowledge of the standard. There are classes that take ~ 1 week. You can also jump straight into a very cost efficient inline training for less than 500$ learn the things in theory and then get certified during that training. It is important to know that you are entitled to perform internal audits then but you will not be entitled to certify companies.

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Karthik Natesan

Hello Karthik - I second with Eckhard's comment on MDR.

To become and ISO 13485 auditor, you can enroll in classes with a notified body like bsi. You can either do online or in-person training. Your prior work experience in the industry will help you understand the ISO 13485 better. This certification will be a good resume booster for you.

Thanks

Karthik

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Karthik Mr

Thanks, Echard Jokisch, and Karthik Natesan.

Your comments helped me out to get this certification done.

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