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Estimation of timeline for ISO 13485 certification
We as a company are thinking about achieving 13485 certification. Is there a rough estimated time schedule on how long the certification process will take starting from zero? We have already looked into the ISO and implemented some processes, however for planning further steps we wanted to setup a timeline.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Verlene Law
May 27, 2019
Answer:
The implementation process will usually take between 3 months to 18 months depending on the size of the company. You can utilize this link to calculate the time that might be needed: https://advisera.com/9001academy/iso-9001-duration-calculator/ For the certificate stage, you should give yourself around 2 months to prepare.
For more information, please read article:
Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
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May 27, 2019
May 27, 2019
May 27, 2019