Minimum time frame to implement ISO 13485 to Stage 1

The time necessary for the implementation of ISO 13485:2016 depends on the number of the employees, how many and how complex your processes are; and what your medical device is (is it low-risk medical device, do you have sterilization process, is it software). Usually, for the company with 10 employees, it is necessary some 2-3 months for companies, and for companies with up to 50 employees, it takes some 6-8 months. 

Here you can find a Checklist of ISO 13485 implementation and certification steps:

• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

Although this article is written for ISO 27001, the content is universal, so maybe you will find it useful:

• The documentation myth – Why the templates are not enough? https://advisera.com/27001academy/blog/2012/04/24/the-documentation-myth-why-the-templates-are-not-enough/