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ISO 13485
What is ISO 13485?
ISO 13485 is an international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Who is the standard intended for?
ISO 13485 is a standard intended primarily for organizations that are involved in one or more stages of the life cycle, including design and development, manufacturing, storage and distribution, installation, or servicing of a medical device.
what do you get
Results after implementation
- guarantee of high quality of services and medical devices provided
- reduces production losses
- reduces operating costs
- increases production efficiency
- increases customer trust
Potrebujete poradiť ohľadne ISO 13485 Systém riadenia kvality zdravotníckych prostriedkov? Neváhajte nás kontaktovať na telefónnom čísle +421 905 325 399, alebo vyplňte krátky formulár nižšie a my vám zavoláme.
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