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

#1
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.
 

Ronen E

Just a person
Super Moderator
#2
Hi,

Is there enough time left to transition to 13485:2016 and MDSAP within a reasonable timeline?
You’ve got a little over a year. If you’re determined you can make it, barely, I think. But don’t waste much more time contemplating or you’ll miss the train.

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

Should we work with external consultants?
Yes, definitely! [I’m a consultant...:lol:]

Should we do 13485:2016 before MDSAP?
I don’t have first-hand experience with MDSAP, but from threads here I gather that it’d 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 I’m told.
 

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