Is there a strong market out there for ISO13485 certification?

C

CJ951

Hi there,

This is my first post on the Cove!

I'm contemplating becoming an ISO 13485 auditor, and I'm curious if it's worth doing, and what the requirements are for becoming one. Is there a strong market out there (in the US especially) for ISO 13485 certification? Are the CBs active with this standard?

Thank you :bigwave:
 

AndyN

Moved On
Hi there,

This is my first post on the Cove!

I'm contemplating becoming an ISO 13485 auditor, and I'm curious if it's worth doing, and what the requirements are for becoming one. Is there a strong market out there (in the US especially) for ISO 13485 certification? Are the CBs active with this standard?

Thank you :bigwave:

It's going to depend a lot on what you are asking as "the market". For a start, not all CBs are accredited for ISO 13485, plus the industry is further segmented by those organizations seeking CMDAS or CE marking for product. Becoming an ISO 13485 auditor may not be as simple as you think. Here, in the USA (since you don't mention where you are located) medical device industries are (in my experience) geographically situated so, this may affect the availability of an audit job, especially since it's smaller companies coming to certification and they don't want to pay for travel...
 

DannyK

Trusted Information Resource
Hi there,

This is my first post on the Cove!

I'm contemplating becoming an ISO 13485 auditor, and I'm curious if it's worth doing, and what the requirements are for becoming one. Is there a strong market out there (in the US especially) for ISO 13485 certification? Are the CBs active with this standard?

Thank you :bigwave:

I am a CMDCAS, CE mark, ISO 13485 lead assessor with a leading certification body.

There seems to be a large demand for qualified auditors with CE marking and CMDCAS requirements.

I know that the certification body I am working with has hired many new full time medical device auditors in the US.

It takes time to get fully qualified so you have to be patient. You can contact some CB if you have experience as a quality manager in medical devices and have taken the ISO 13485 lead assessor course.

Danny
 

pkost

Trusted Information Resource
ISO 13485 only I'm not sure about,

certainly in the EU (and presumably with all EU NB's) there is a heavy demand for technical reviewers, if they have the ability to audit 13485 I imagine it would be a plus. I am contacted on almost a weekly basis to ask if I'm interested; I can also see evidence of this from the fact that it takes months to schedule a simple file review.:mad:

MDD (and soon MDR) requirements are becoming more burdensome, this is being passed on to the NB auditors to assess. It is going to have to be resourced somehow.
 
C

CJ951

Thanks for the responses so far!

I am located in the US for anybody wondering.

I would appreciate some more opinions!
 

AndyN

Moved On
quick bump!

Hi - I'm not sure you'll get many more answers. A quick review pretty much has all angles covered...
Anyone else isn't likely to tell you anything new/different, as the replies come from the core of people in the industry.
 
C

CJ951

I'm interested in hearing from more 13485 lead assessors, like Danny, about whether or not the CBs are active with this standard, and whether or not it's worth me to pursue as an auditor :D
 
Last edited by a moderator:

AndyN

Moved On
I'm interested in hearing from more 13485 lead assessors, like Danny, about whether or not the CBs are active with this standard, and whether or not it's worth me to pursue as an auditor :D

I'm in sales for a leading accredited CB and I can confirm there's activity with this standard.
 
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