Quality Management ISO 13485
QbD’s experienced quality managers will assist you in setting up your QMS.
The objective of ISO 13485:200
ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate and ensure harmonized medical device regulatory requirements for quality management systems.
All the requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
How we support you
Why opt for the QbD Group?
Your QMS is a matter of quality, and quality matters to us.
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