Quality is not accidental, it is the result of effective business processes by KORN CONSULT GROUP®

ISO 13485 – in the Health Care Sector/Medical Technology

A new customer in the healthcare industry/medical technology from Germany has commissioned KORN CONSULT GROUP with an ISO 13485 – Conformity Analysis and Implementation.

The medical device manufacturer was certified according to ISO 9001:2015 and would now like to upgrade to the ISO 13485 management system.
After a gap analysis, our industry-experienced Consultant prepared an assessment regarding project content, scope and necessary resources.

Based on the analysis, the implementation and enablement of the customer was successfully realized as part of the joint implementation project.

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