Would becoming ISO 13485 compliant benefit customers more than ISO 9001?

Answer:

Yes, because ISO 13485 is made strictly for the manufacturer of medical devices. ISO 13485 allows a company to demonstrate that it consistently meets customer's needs, medical device regulatory requirements and complies with local legislation. It is, in certain points, related to ISO 9001, but ISO 13485 emphasizes areas such as risk management, the work environment, and medical device documentation and reporting.

For more information about ISO 13485 structure and requirements, please read the following article:
ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/

For more information about similarities beteweed FDA nad ISO 13 485, please read the following link:
https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/
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