ISO 13485 certification
-
Published4 Oct 2025
-
Author
- Topics Archive
iso 13485 certification
For companies involved in producing medical devices, ISO 13485 certification is often a prerequisite for market access in many countries. This certification facilitates regulatory approvals, such as CE marking in Europe and FDA acceptance in the United States. By implementing ISO 13485, organizations can reduce risks associated with product failures and recalls, thereby protecting patients and their brand reputation.
