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Implementation duration

ISO 13485 & EU MDR
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Guest user Created:   Apr 23, 2021 Last commented:   Apr 26, 2021

Implementation duration

ISO 13485 & EU MDR
I have a question for you. I am experienced with ISO9001 and 13485.  Conducted many audits as the company representative. I am working with a small startup site, no employees or equipment yet and am tasked with putting in a 13485 system in an ISO8 cleanroom operation. Using your toolkit and no employees, other than a few senior leadership individuals who will not help much, how long should I allocate to getting all the procedures in place to pass an audit?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Kristina Zvonar Brkić Apr 26, 2021

We estimate that for companies up to 10 employees it is necessary up to 3 months to implement the quality management system according to the ISO 13485:2016.

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