Price:$67.26

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ISO 13485:2016 Full QMS Documentation Templates

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Highlights

  • Designed by QualityStoreByBanu
  • Party decor for gatherings and celebrations
  • Digital download
  • Digital file type(s): 1 File

Is it not preferable to possess ISO 13485 QMS document templates (including procedures, plans, forms, matrices, lists, logs, and policy templates) along with examples readily available before the surveillance audit, ensuring they comply with the full MDR requirements?

Here's the extensive 13485 QMS Package available for your reference

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Reviews for this item

3.8

We calculate this number using a recency-weighted average of all ratings, with a rating's value decreasing by half each year to best reflect the current experience.

(4 reviews)

5.0 Item quality
5.0 Shipping
5.0 Customer service
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5 out of 5 stars 5 This item

Eddie Jul 28, 2023

quality item and very useful

Eddie Jul 28, 2023

Response from banu

Thanks Eddie, glad to know it was useful for you.

4 out of 5 stars 4 This item

Eric Jul 28, 2023

Helpful resources at reasonable price

Eric Jul 28, 2023

Response from banu

Thanks for your feedback. I'am glad to hear it was helpful for you.

5 out of 5 stars 5 This item

Beste Nov 30, 2023

Dear Ms. Guer, Thank you very much for everything. I am sure your documents will be very useful for my progress. Best regards, B. Bird

Beste Nov 30, 2023

Response from banu

Sehr geehrte Frau Vogel, Ich hoffe, dass der Leitfaden und die Dokumentation für Sie von Nutzen sein werden. Mit herzlichen Grüßen

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1 out of 5 stars 1 This item

amel Jul 29, 2023

The quality of the documents and forms provided do not meet the requirements of the ISO 13485 standard: - several required procedures are missing - the content itself of each document does not meet the requirements

amel Jul 29, 2023

QualityStoreByBanu
QualityStoreByBanu ·

United States

We calculate this number using a recency-weighted average of all ratings, with a rating's value decreasing by half each year to best reflect the current experience. 3.7
·
121 sales
·
2.5 years on Etsy

Typically responds within a few hours

Typically responds within a few hours

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Listed on Mar 27, 2026