INTERNAL AUDIT, ISO13485/MDR/IVDR

from €1,500.00

Objective:

To assess the conformity of the quality system, identify non-conformities and areas for improvement, and ensure regulatory compliance prior to external audits or inspections by competent authorities.

This is a specialized internal audit service for companies in the medical device and in vitro diagnostic device sectors.

The service evaluates your organization’s Quality Management System compliance with:

ISO 13485:2016

Regulation (EU) 2017/745 (MDR)

Regulation (EU) 2017/746 (IVDR)

Not included:

If the audit takes place outside of Catalonia, transportation and accommodation are not included. The price may increase if audit exceed 3 total days.

Price excluding VAT