Medical Device Quality Management
In the medical device sector the EN ISO 13485 standard 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 according to the medical device directives. The primary objective of the EN ISO 13485 standard is to facilitate global harmonized requirements for medical device quality management systems, regardless of the type or size of the organization and the device.
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- QMS implementation
- QMS internal audits, process analysis, GAP-analysis
- QMS documentation
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