Menu Close

Quality Management ISO 13485

ISO 13485:2003 specifies certain requirements for a quality management system in the medical device industry.

QbD’s experienced quality managers will assist you in setting up your QMS.
Quality Management ISO

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

ASQ certified quality auditor

Why opt for the QbD Group?

Your QMS is a matter of quality, and quality matters to us.

10+ years of experience

Benefit from our team of highly qualified consultants.

Full life cycle support

Full support from pre- to the post-marketing phase.

Global presence

QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.

Customer satisfaction

Constant evaluation, transparency and clear objectives.

Contact us

Talk to an expert

Contact us for more information or to request a free, no-obligation proposal.