09 Apr ISO 13485 Certificate as a prerequisite for the approval of a Medical Device Establishment Licence
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The international standard ISO 13485 for a quality management system (QMS) is recognised globally to address minimum regulatory requirements for medical devices and in vitro diagnostics (IVDs). The standard outlines the requirements for manufacturers and suppliers of medical devices and IVDs, and it establishes a minimum quality assurance framework to ensure medical devices and IVDs are managed appropriately to provide medical devices and IVDs which are safe and perform as intended by the manufacturer.
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Document Number:
MD01-2025/2026
Version:
1
Date Updated:
09/04/2025
File Type:
pdf
Category:
Communication to industry