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Is there enough time left to transition to ISO 13485:2016 and MDSAP?
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Is there enough time left to transition to ISO 13485:2016 and MDSAP?
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Is there enough time left to transition to ISO 13485:2016 and MDSAP?

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iso 13485:2016, mdsap (medical device single audit program), transition (between standards or revisions to a standard)
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  Post Number #1  
Old 10th November 2017, 10:23 PM
snoopy2017

 
 
Total Posts: 91
Question Is there enough time left to transition to ISO 13485:2016 and MDSAP?

Hi everyone,

My company has not started the transition to 13485:2016. Is there enough time left to transition to 13485:2016 and MDSAP within a reasonable timeline? The company is very small and doesn't have too much resources. What is the best approach to this transition? Should we work with external consultants?
Should we do 13485:2016 before MDSAP? This is a very small company.

Thank you very much. I look forward to hearing your suggestions.

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  Post Number #2  
Old 11th November 2017, 01:56 AM
Ronen E

 
 
Total Posts: 3,736
Re: Is there enough time left to transition to ISO 13485:2016 and MDSAP?

Hi,

Quote:
In Reply to Parent Post by snoopy2017 View Post

Is there enough time left to transition to 13485:2016 and MDSAP within a reasonable timeline?
Youíve got a little over a year. If youíre determined you can make it, barely, I think. But donít waste much more time contemplating or youíll miss the train.

(MDSAP currently has a mandatory timeline only for Canada.)

Quote:
In Reply to Parent Post by snoopy2017 View Post

Should we work with external consultants?
Yes, definitely! [Iím a consultant...]

Quote:
In Reply to Parent Post by snoopy2017 View Post

Should we do 13485:2016 before MDSAP?
I donít have first-hand experience with MDSAP, but from threads here I gather that itíd be a waste of resources to do it separately. MDSAP (with 13485 inc.) is resources-hungry, yet it would take even more resources to do it in 2 stages, or so Iím told.
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